Waukegan, IL, United States
Cardinal Health 200, LLC recalls
57 recalls recorded since 2018, most recently on 19 August 2026. 30 are listed as ongoing. Status and classification are as published by the FDA.
Recalls57
Ongoing (FDA)30
Terminated or completed27
Class I (FDA)6
Ongoing Class II Medical devices
- Recall started
- 19 August 2026
- Reason
- Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a procedure. The issue can result in a delay to treatment and unintended extubation. The potential exists for respiratory failure, hypoxia, aspiration, or low oxygen saturation.
- Distribution
- Pending
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0079-2027
- Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit Catalog Number OMSVM4166A Intubation UH Kit Cata
Ongoing Class II Medical devices
- Recall started
- 18 August 2026
- Reason
- The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
- Distribution
- US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3297-2026, Z-3296-2026, Z-3298-2026, Z-3295-2026
- Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA1; 3) KIT, GYN LAPAROSC
- Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU; 2) KIT,GU DAVINCI , Catalog Number: PGVMDVBWV; 3) KIT,GU DAVINCI
- Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
- Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number: PGCGLCBAD; 3) KIT, LAP CHOLE
Ongoing Class II Medical devices
- Recall started
- 10 August 2026
- Reason
- The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.
- Distribution
- US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3254-2026, Z-3255-2026
- Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT, PRE PROCEDURE , Catalog Number: IVSJV8302E
- Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15
Ongoing Class II Medical devices
- Recall started
- 29 July 2026
- Reason
- The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3103-2026, Z-3095-2026, Z-3102-2026, Z-3099-2026, Z-3104-2026, Z-3100-2026, Z-3105-2026, Z-3101-2026, Z-3097-2026, Z-3096-2026, Z-3094-2026, Z-3098-2026
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI, Catalog Number: KIT, BLO LAVH ; 2) PB15HYFCY, Catalog Number: KIT, UMMC AB HYST II 170032 ; 3) S
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC GSAM , Catalog Number: PBCCGRSGD; 2) KIT, GYN ROBOT ACCESSORY , Catalog Number: PB35GYBJC; 3) K
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM3; 2) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM4; 3) K
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number: PWV2MF01D
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLMC CRANIOTOMY , Catalog Number: PNCGCNAUM; 2) KIT, ORP MAJOR SPINE , Catalog Number: PNHDFSVCI; 3) K
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT HARVEST , Catalog Number: PEVMETBJX; 2) KIT, ENT HARVEST , Catalog Number: PEVMETB37
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO MAJOR SPINE , Catalog Number: POV2SCCPP; 2) KIT,ORTHOPLASTIC MICROVASCULAR, Catalog Number: PWVMFFABLI
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, BLO ROBOTIC GYN , Catalog Number: PBCGRGB28; 2) KIT , GYN MAJOR BARNES JEWIS, Catalog Number: PBVMLP22G; 3) K
- and 4 more product lines
Ongoing Class II Medical devices
- Recall started
- 14 July 2026
- Reason
- Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Distribution
- US Nationwide. Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2945-2026, Z-2943-2026, Z-2948-2026, Z-2942-2026, Z-2947-2026, Z-2944-2026, Z-2946-2026, Z-2949-2026
- Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB;
- Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
- Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH
- Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4
- Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2
- Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
- Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catalog Number: SNE30CRJG
- Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11S
Ongoing Class I Drugs
- Recall started
- 2 March 2026
- Reason
- Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
- Distribution
- Nationwide within the United States, Puerto Rico and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0528-2026
- Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.
Ongoing Class II Medical devices
- Recall started
- 27 February 2026
- Reason
- The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1768-2026
- Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
Ongoing Class II Medical devices
- Recall started
- 26 December 2025
- Reason
- The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Chile, Colombia, Dominican Republic, and Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1203-2026
- Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Se
Ongoing Class II Medical devices
- Recall started
- 12 November 2025
- Reason
- Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0897-2026
- ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-steril
Ongoing Class II Medical devices
- Recall started
- 18 September 2025
- Reason
- Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Au
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0208-2026, Z-0207-2026, Z-0211-2026, Z-0209-2026, Z-0206-2026, Z-0210-2026
- Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 8888265116 Salem Sump Silicone Dual Lumen Stomach Tube, Radiop
- Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 264960 Salem Sump" Stomach Tube, Dual L
- Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 1180264424 Salem
- Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve
- Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E
- Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) 266130 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 16 Fr/Ch (5.
Completed Class II Medical devices
- Recall started
- 13 May 2025
- Reason
- Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
- Distribution
- Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1917-2025, Z-1919-2025, Z-1918-2025
- SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
- Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
- Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Ongoing Class II Medical devices
- Recall started
- 2 May 2025
- Reason
- Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Afr
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1870-2025, Z-1871-2025, Z-1872-2025, Z-1873-2025, Z-1875-2025, Z-1874-2025
- Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
- Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
- Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
- Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
- Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
- Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Ongoing Class II Medical devices
- Recall started
- 8 November 2024
- Reason
- Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1132-2025, Z-1126-2025, Z-1128-2025, Z-1131-2025, Z-1133-2025, Z-1129-2025, Z-1130-2025, Z-1135-2025, Z-1134-2025, Z-1127-2025, Z-1137-2025, Z-1136-2025
- Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG6 4) KIT,
- Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) K
- Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC
- Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
- Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC
- Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D 3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA103 4) KIT,CAROTI
- Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4)
- Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, C
- and 4 more product lines
Ongoing Class II Medical devices
- Recall started
- 8 November 2024
- Reason
- Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0910-2025, Z-0917-2025, Z-0914-2025, Z-0915-2025, Z-0916-2025, Z-0908-2025, Z-0912-2025, Z-0911-2025, Z-0913-2025, Z-0909-2025
- Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM5; 4 ) ANEURYSM PACK , Catalog Number: SCVH
- Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; 3) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH2; 4) KIT,H N FREE FLAP , Catal
- Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH6 4 ) KIT, FETAL SURGERY , Catalog Nu
- Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43; 4) CHI STD NEURO CR
- Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM5; 4)
- Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLASTIC FLAP,Catalog Num
- Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH3 ; 3 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH4 ; 4 ) LARYNGOSCOPY PACK, Catal
- Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI
- and 2 more product lines
Ongoing Class II Medical devices
- Recall started
- 1 November 2024
- Reason
- Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.
- Distribution
- US Nationwide. Canada, UAE
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0675-2025, Z-0674-2025
- Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL
- Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Ongoing Class I Medical devices
- Recall started
- 25 September 2024
- Reason
- Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0310-2025
- Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Ongoing Class II Medical devices
- Recall started
- 24 July 2024
- Reason
- The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
- Distribution
- Distribution was nationwide, including Puerto Rico and Guam. There was also government/military distribution. Foreign distribution was made to Chile.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3302-2024, Z-3301-2024
- (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Val
- (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Mode
Ongoing Class II Medical devices
- Recall started
- 29 May 2024
- Reason
- Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2329-2024, Z-2330-2024, Z-2328-2024, Z-2327-2024
- Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC4; 3) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCL
- Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog
- Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10; 3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11
- Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPHY PACK, Catalog Numb
Ongoing Class II Medical devices
- Recall started
- 17 April 2024
- Reason
- Potential contamination of the product with latex adhesive residual.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1835-2024
- CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.
Ongoing Class II Medical devices
- Recall started
- 27 March 2024
- Reason
- Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Guatemala, Chile, Caribbean Island, Costa Rica.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1735-2024, Z-1738-2024, Z-1736-2024, Z-1739-2024, Z-1737-2024
- Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D
- Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601
- Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D
- Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
- Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D
Ongoing Class I Medical devices
- Recall started
- 28 December 2023
- Reason
- Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
- Distribution
- Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0858-2024, Z-0849-2024, Z-0855-2024, Z-0854-2024, Z-0847-2024, Z-0852-2024, Z-0851-2024, Z-0848-2024, Z-0853-2024, Z-0850-2024, Z-0859-2024, Z-0856-2024 and 1 more
- Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
- Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
- Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
- Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T
- Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
- Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
- Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
- Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
- and 5 more product lines
Terminated Class II Medical devices
- Recall started
- 21 December 2023
- Terminated
- 9 October 2026
- Reason
- The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.
- Distribution
- US, Canada, Australia and New Zealand
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0754-2024, Z-0756-2024, Z-0755-2024
- CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510
- Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651-517
- Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516
Completed Class I Medical devices
- Recall started
- 4 December 2023
- Reason
- Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- Distribution
- US and EMEA, Japan, Latin America
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1049-2024, Z-1044-2024, Z-1045-2024, Z-1051-2024, Z-1048-2024, Z-1050-2024, Z-1047-2024, Z-1043-2024, Z-1046-2024, Z-1052-2024
- Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
- TRACH KIT W/HYDROGEN & SALI
- Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000
- Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
- Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX
- Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 M
- Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC, CSD; Dover" 100% SIL
- Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline, 6 Fr/Ch (2.0 mm); Argyle" Graduated Suction Catheter Tray with Chimney Va
- and 2 more product lines
Ongoing Class I Medical devices
- Recall started
- 20 September 2023
- Reason
- Demonstrated recognition and compatibility issues with syringe infusion pumps.
- Distribution
- US Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0145-2024, Z-0148-2024, Z-0150-2024, Z-0147-2024, Z-0146-2024, Z-0149-2024
- Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
- Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
- Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
- Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
- Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
- Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
Ongoing Class II Medical devices
- Recall started
- 13 September 2023
- Reason
- Syringe contains conical tip that is not compatible with certain needleless IV connector(s).
- Distribution
- Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0112-2024
- Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
Ongoing Class II Medical devices
- Recall started
- 16 August 2023
- Reason
- Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0090-2024, Z-0085-2024, Z-0083-2024, Z-0091-2024, Z-0087-2024, Z-0092-2024, Z-0084-2024, Z-0089-2024, Z-0088-2024, Z-0086-2024
- Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.
- Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.
- Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa.
- Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Sterile; (3) Presource PBDS Cat. PODKHAKAB, Kit, Hip Arthroscopy, Sterile; (4) Presource
- Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2) Presource PBDS Cat. PGVGLBP20, Parkview Medical Center, Kit, Lap Chole, Sterile; (3) Presource PBD
- Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile.
- Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular. (3) Presource PBDS
- Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile; (2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile; (3) Presource PBDS Cat. PN08LAG17, Kit, Spine, Sterile; (4) Presource PBDS, Cat.
- and 2 more product lines
Ongoing Class II Medical devices
- Recall started
- 16 June 2023
- Reason
- Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2147-2023
- NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Ongoing Class II Medical devices
- Recall started
- 6 April 2023
- Reason
- Inadvertently released for distibution without sterility assurance.
- Distribution
- Distribution in the US to Georgia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1690-2023
- Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Ongoing Class II Medical devices
- Recall started
- 14 December 2022
- Reason
- Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia, Singapore, Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0994-2023, Z-0970-2023, Z-0991-2023, Z-0980-2023, Z-0982-2023, Z-0985-2023, Z-0975-2023, Z-0983-2023, Z-0971-2023, Z-0968-2023, Z-0977-2023, Z-0967-2023 and 16 more
- Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292
- Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189
- Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233
- Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217
- Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223
- Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227
- Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212
- Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225
- and 20 more product lines
Ongoing Class II Medical devices
- Recall started
- 18 November 2022
- Reason
- Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity
- Distribution
- US Nationwide distribution in the states of GA, PA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1158-2023, Z-1159-2023, Z-1157-2023
- Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
- Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E
- Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B
Ongoing Class II Medical devices
- Recall started
- 28 September 2022
- Reason
- Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
- Distribution
- nationwide and Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0186-2023, Z-0191-2023, Z-0192-2023, Z-0189-2023, Z-0190-2023, Z-0185-2023, Z-0187-2023, Z-0188-2023
- Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204
- Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600
- Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
- Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A
- Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A
- Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
- Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
- Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104
Completed Class II Medical devices
- Recall started
- 15 March 2022
- Reason
- Product was distributed without being sterilized.
- Distribution
- Product distributed throughout United States and Guam
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0902-2022
- Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Terminated Class I Medical devices
- Recall started
- 16 June 2021
- Terminated
- 4 January 2023
- Reason
- The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2244-2021
- Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201
Terminated Class II Medical devices
- Recall started
- 9 June 2021
- Terminated
- 1 November 2023
- Reason
- A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.
- Distribution
- US Nationwide Distribution to states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA ,ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2094-2021, Z-2095-2021
- Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an
- Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing
Terminated Class II Medical devices
- Recall started
- 21 May 2021
- Terminated
- 8 January 2024
- Reason
- The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2036-2021, Z-2035-2021, Z-2031-2021, Z-2038-2021, Z-2032-2021, Z-2034-2021, Z-2037-2021, Z-2033-2021
- Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision fr
- Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial
- Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other
- Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and ot
- Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and ot
- Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contami
- Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other co
- Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contaminati
Terminated Class II Medical devices
- Recall started
- 25 February 2021
- Terminated
- 9 January 2024
- Reason
- Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.
- Distribution
- Distributed nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Distributed also to Australia and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1300-2021, Z-1301-2021, Z-1304-2021, Z-1303-2021, Z-1302-2021
- In-View Clear Leggings Sterile
- In-View Clear Leggings Sterile Non-Sterile
- Femoral Angiography Drape Bulk Non-Sterile
- Femoral Angiography Drape Sterile
- In-View Clear Leggings Bulk Non-Sterile
Terminated Class II Medical devices
- Recall started
- 11 February 2021
- Terminated
- 22 December 2022
- Reason
- Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect medication label sheet throughout the specific Presource¿ kit SANHDJTVCF Judkins Pack lot # 525067.
- Distribution
- US state of VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1256-2021
Terminated Class II Medical devices
- Recall started
- 9 February 2021
- Terminated
- 9 April 2024
- Reason
- Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of AE, Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1251-2021, Z-1252-2021, Z-1250-2021
- McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 26558
- Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. P
- Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881850
Completed Class II Medical devices
- Recall started
- 19 January 2021
- Reason
- The potential for air appearing in the enteral feed pumping set tubing during set-up.
- Distribution
- Domestic: All 50 states and DC, Foreign: Argentina, Australia, Brazil, Canada, Chile, Colombia, Japan, Mexico, Netherlands, Panama, Peru, Puerto Rico, Singapore, Switzerland, Turkey
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1347-2021
Ongoing Class II Medical devices
- Recall started
- 7 January 2021
- Reason
- There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
- Distribution
- Global Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA , WA, WI and WY including Puerto Rico; and OUS (countries) of: Australia, Ca
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1090-2021, Z-1088-2021, Z-1087-2021, Z-1094-2021, Z-1086-2021, Z-1089-2021, Z-1092-2021, Z-1095-2021, Z-1093-2021, Z-1085-2021, Z-1091-2021, Z-1097-2021 and 1 more
- Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the
- Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from
- Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health c
- Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from t
- Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from t
- Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the t
- Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the
- Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the trans
- and 5 more product lines
Terminated Class II Medical devices
- Recall started
- 7 January 2021
- Terminated
- 14 February 2024
- Reason
- Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
- Distribution
- Global Distribution. US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1082-2021, Z-1081-2021, Z-1078-2021, Z-1083-2021, Z-1079-2021, Z-1080-2021
- Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K
- ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K
- Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K
- ChemoPlus" Chemo Prep & Admin Kit, CT4025
- CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K
- CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004
Terminated Class II Medical devices
- Recall started
- 25 September 2020
- Terminated
- 30 October 2023
- Reason
- Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated, the needle can fall out of the sheath and cause the unused needle to project out of the cartridge, and result in a needle stick/puncture from the clean/unused needle
- Distribution
- Distribution US Nationwide, Australia and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0424-2021
- Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of medication from a container, aspiration of fluid from a patient, injection of medi
Ongoing Class II Medical devices
- Recall started
- 22 September 2020
- Reason
- The feeding spike sets may leak at the interface of the tube and spike connector.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0453-2021, Z-0452-2021
- Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
- Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
Terminated Class II Medical devices
- Recall started
- 30 July 2020
- Terminated
- 28 April 2021
- Reason
- Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
- Distribution
- US Nationwide distribution including the state of North Carolina.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3016-2020
- KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
Completed Class II Medical devices
- Recall started
- 29 July 2020
- Reason
- A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
- Distribution
- US Nationwide distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2913-2020, Z-2918-2020, Z-2916-2020, Z-2912-2020, Z-2917-2020, Z-2919-2020, Z-2915-2020, Z-2914-2020
- PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier
- PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier
- PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier
- PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier
- PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier
- PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier
- PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier
- PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier
Terminated Class II Medical devices
- Recall started
- 4 June 2020
- Terminated
- 5 August 2025
- Reason
- Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2543-2020, Z-2544-2020
- Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulce
- Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness bu
Terminated Class II Medical devices
- Recall started
- 31 January 2020
- Terminated
- 19 January 2023
- Reason
- The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1235-2020
- Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
Terminated Class II Medical devices
- Recall started
- 31 January 2020
- Terminated
- 1 February 2023
- Reason
- The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
- Distribution
- US Nationwide. Chile, Israel, UAE.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1301-2020
- Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
Terminated Class II Medical devices
- Recall started
- 15 January 2020
- Terminated
- 4 December 2020
- Reason
- Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.
- Distribution
- Worldwide distributions - US Nationwide distributions in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and countries of Canada, Australia, S
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1454-2020, Z-1453-2020, Z-1455-2020, Z-1456-2020
- Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
- Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surfac
- Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
- Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid from a vial - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body
Terminated Class II Medical devices
- Recall started
- 28 October 2019
- Terminated
- 17 May 2022
- Reason
- The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.
- Distribution
- Worldwide Distribution - US Nationwide and Foreign in the countries of: Australia Austria Belgium Canada Canary Islands Chile Costa Rica Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Guiana French Polynesia Gabon Germany Gibraltar Greece Guadeloupe
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0992-2020, Z-0994-2020, Z-0990-2020, Z-0991-2020, Z-0993-2020
- Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062
- Genius 2 Tympanic Thermometer Private Label Item Code: 3069
- Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000
- Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
- Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063
Completed Class II Medical devices
- Recall started
- 30 April 2019
- Reason
- Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- Distribution
- Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2042-2019, Z-2041-2019, Z-2037-2019, Z-2039-2019, Z-2049-2019, Z-2036-2019, Z-2052-2019, Z-2045-2019, Z-2043-2019, Z-2044-2019, Z-2048-2019, Z-2051-2019 and 5 more
- Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664
- Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508
- Monoject Standard Hypodermic Needle Item code: 8881200029
- Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045
- Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322
- Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011
- Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389
- Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522
- and 9 more product lines
Terminated Class II Medical devices
- Recall started
- 22 March 2019
- Terminated
- 6 August 2021
- Reason
- Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
- Distribution
- Worldwide Distribution - US Nationwide: Foreign: Bahamas, Canada, Chile, Guam, Israel, Japan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1283-2019, Z-1286-2019, Z-1285-2019, Z-1284-2019
- ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
- ChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
- ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
- ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
Terminated Class II Medical devices
- Recall started
- 27 December 2018
- Terminated
- 29 June 2020
- Reason
- Curity All Purpose Sponges were not sterilized and distributed
- Distribution
- Worldwide distribution - US Nationwide and countries of Canada, Colombia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0957-2019
- Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal for applying ointments, prepping, wiping needles, cleaning slides and more Rayon/polyester blend cons
Terminated Class II Medical devices
- Recall started
- 31 October 2018
- Terminated
- 12 August 2025
- Reason
- Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.
- Distribution
- Worldwide Distribution: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and to countries of: Austria, Belg
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0637-2019, Z-0631-2019, Z-0638-2019, Z-0633-2019, Z-0635-2019, Z-0634-2019, Z-0632-2019, Z-0636-2019
- Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a sur
- Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a sur
- Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a sur
- Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel
- Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a sur
- Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a sur
- Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a s
- Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a sur
Terminated Class II Medical devices
- Recall started
- 11 June 2018
- Terminated
- 17 August 2020
- Reason
- The suction valve may not close properly which could cause continuous suction.
- Distribution
- Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherl
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2493-2018, Z-2487-2018, Z-2490-2018, Z-2488-2018, Z-2486-2018, Z-2492-2018, Z-2491-2018, Z-2494-2018, Z-2495-2018, Z-2485-2018, Z-2489-2018
- Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref ASU1211, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Manufactured For Cardinal Health, Waukegan, IL.
- Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Double Spike, Ref ASC1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
- Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike, Ref ASU1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
- Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Single Spike and no Probe, Ref ASC1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
- Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Single Spike, Ref ASC1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
- Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike, Ref ASU1210, packaged 1/box, 12 boxes/case, single use, RX, Sterile. .
- Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref ASU1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
- Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
- and 3 more product lines
Terminated Class II Medical devices
- Recall started
- 28 March 2018
- Terminated
- 29 November 2018
- Reason
- products may be missing a one-way valve on the fluid patient port.
- Distribution
- US Distribution to the state of MA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1546-2018
- Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedu
Terminated Class II Medical devices
- Recall started
- 20 February 2018
- Terminated
- 4 November 2019
- Reason
- A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.
- Distribution
- US Nationwide Distribution in the states of California.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2481-2018, Z-2483-2018, Z-2480-2018, Z-2482-2018
- Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: Th
- Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product
- Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product U
- Presource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage:
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.