Reading, PA, United States
Arrow International Inc recalls
54 recalls recorded since 2018, most recently on 21 April 2026. 14 are listed as ongoing. Status and classification are as published by the FDA.
Recalls54
Ongoing (FDA)14
Terminated or completed40
Class I (FDA)10
Ongoing Class I Medical devices
- Recall started
- 21 April 2026
- Reason
- Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- Distribution
- US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2379-2026, Z-2371-2026, Z-2388-2026, Z-2385-2026, Z-2386-2026, Z-2377-2026, Z-2370-2026, Z-2387-2026, Z-2384-2026, Z-2392-2026, Z-2391-2026, Z-2374-2026 and 23 more
- Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 15 CM/CDC-41552-JX1
- Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EPIDURAL CATHETERIZATION KIT/AK-05502; EPIDURAL CATHETERIZATION KIT/AK-05502D; EPIDURAL CATHETERIZAT
- Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK-12123-UOC1, AHDC KIT: 3-L 12 FR X 16 CM/ASK-12123-UPM, AHDC KIT: 3L 12 FR X 20 CM/ASK-15123-UOC1, AHDC KIT: 3-L 12 FR X
- Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH; PSI KIT: 9 FR X 10 CM/ASK-09903-PHP1; P
- Description/REF: PARACENTESIS KIT/ASK-00376-JHH
- Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSEL CATH KIT: 20GA X 5IN/AK-04550-S CVC KI
- Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS AGBA PICC/DELTA KIT: 1L 4.5 FR X 55 CM/ASK-45541-MHBV PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS/ASK-4555
- Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC
- and 27 more product lines
Ongoing Class I Medical devices
- Recall started
- 10 April 2026
- Reason
- 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
- Distribution
- Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2157-2026, Z-2156-2026, Z-2159-2026, Z-2158-2026
- Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272-VFI, CS-15272-VFIE, CS-15312-VFI, CS-15
- Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
- NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysis Catheter with Ar
- Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter with Arrow Simplicity Micro-Introducer,
Ongoing Class II Medical devices
- Recall started
- 11 March 2026
- Reason
- Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1916-2026, Z-1911-2026, Z-1914-2026, Z-1913-2026, Z-1912-2026, Z-1915-2026, Z-1910-2026, Z-1917-2026
- MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits sh
- ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 REF AS
- ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)1080190222
- FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 The Arrow Epidural Catheter kit permits acce
- PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿ percutaneous sheath introducer permits venous access and catheter
- Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology is intended to provide protection against cath
- Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers
- Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Acces
Ongoing Class II Medical devices
- Recall started
- 26 July 2024
- Reason
- Reports have been received regarding open seals on the packaging.
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, IL, MA, ME, MI, NC, NY, PA, and WV. There was government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3299-2024
- Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Cath
Ongoing Class I Medical devices
- Recall started
- 29 April 2024
- Reason
- Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, AU, BA, BE, BG, BN, CA, CL, CN, CO, CY, CZ, DE, EC, ES, FR, GB, GP, GR, HU, HK, IE, IL, IN, IQ, IT, JO, JP, KW, KZ, LB, LU, MA, MN, MK, MX, MY, NL, OM, PA, PF, PH, PL, PT, QA, RE, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, UZ, ZA, and UAE.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1878-2024, Z-1879-2024, Z-1880-2024
- Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
- Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
- Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
Ongoing Class I Medical devices
- Recall started
- 12 February 2024
- Reason
- Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire handle/chamber during use. The possible immediate health consequences of the component issue are arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.
- Distribution
- Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: AE, AR, AT, AU, BE, BH, BR, CA, CN, CO, CY, DE, EC, EE, ES, FR, GR, HK, HR, IT, KW, LB, LU, MX, MY, NL, NZ, PH, PL, QA, RU, SA, SE, SG, SI, TH, TW, and UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1267-2024
- ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF ASK-04220-HHC; d) REF ASK-04220-KSP; e) REF ASK-04220-PSU; f) REF ASK-04220-
Ongoing Class II Medical devices
- Recall started
- 10 August 2023
- Reason
- This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2590-2023, Z-2591-2023
- Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
- Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter
Ongoing Class I Medical devices
- Recall started
- 10 August 2023
- Reason
- This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- Distribution
- US
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0004-2024, Z-0002-2024, Z-0001-2024, Z-0003-2024
- Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
- Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
- Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnos
- Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Ongoing Class I Medical devices
- Recall started
- 19 May 2023
- Reason
- Potential for catheter separation or leakage
- Distribution
- Nationwide distribution. International distribution to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1826-2023
- ARROW Endurance Extended Dwell Peripheral Catheter System
Terminated Class I Medical devices
- Recall started
- 27 October 2022
- Terminated
- 7 October 2024
- Reason
- There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.
- Distribution
- US Distributor in states of: FL, GA, KY, OH, PA and WV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0352-2023, Z-0351-2023
- Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-
- Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
Ongoing Class I Medical devices
- Recall started
- 17 October 2022
- Reason
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0432-2023, Z-0455-2023, Z-0431-2023, Z-0438-2023, Z-0442-2023, Z-0428-2023, Z-0433-2023, Z-0454-2023, Z-0453-2023, Z-0426-2023, Z-0446-2023, Z-0450-2023 and 19 more
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
- Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
- Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
- Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
- Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
- and 23 more product lines
Terminated Class II Medical devices
- Recall started
- 14 September 2022
- Terminated
- 19 January 2024
- Reason
- Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1).
- Distribution
- US Nationwide distribution in the state of Florida.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0102-2023
- ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion,
Terminated Class II Medical devices
- Recall started
- 5 May 2022
- Terminated
- 4 September 2024
- Reason
- Gravity flow rates on the affected product lidstock are incorrect.
- Distribution
- US Nationwide distribution in the states of Florida.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1290-2022
Terminated Class I Medical devices
- Recall started
- 20 September 2021
- Terminated
- 5 October 2023
- Reason
- 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
- Distribution
- Worldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: BE CA CL CZ DE ES FR IL IT KR PH SA TR TW UK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0233-2022, Z-0234-2022, Z-0232-2022, Z-0231-2022
- Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive U
- Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive
- Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Driv
- Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive
Ongoing Class II Medical devices
- Recall started
- 19 May 2021
- Reason
- Marketed without a 510K
- Distribution
- US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2068-2021, Z-2069-2021, Z-2070-2021, Z-2071-2021
- Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
- Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or
- Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
- Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/o
Ongoing Class II Medical devices
- Recall started
- 8 March 2021
- Reason
- Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biopsy, leading to a prolonged procedure
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1374-2021
- Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of
Terminated Class II Medical devices
- Recall started
- 6 January 2021
- Terminated
- 12 July 2022
- Reason
- The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A and not identify the product as a coated ARROWg+ard Blue PLUS (AGB+) antimicrobial catheter which may cause a minor delay during use and placement of a coated catheter in patients with known sensitivity to chlorohexidine, silver sulfadiazine or sulfa could result in an allergic reaction
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1106-2021
- Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A
Terminated Class II Medical devices
- Recall started
- 6 July 2020
- Terminated
- 5 November 2021
- Reason
- The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.
- Distribution
- World wide distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2802-2020, Z-2804-2020, Z-2801-2020, Z-2803-2020
- Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been damaged.
- NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.
- Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural space.
- Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space.
Terminated Class I Medical devices
- Recall started
- 20 May 2020
- Terminated
- 7 January 2023
- Reason
- A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2410-2020, Z-2417-2020, Z-2413-2020, Z-2408-2020, Z-2414-2020, Z-2412-2020, Z-2416-2020, Z-2415-2020, Z-2411-2020, Z-2409-2020
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
- Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
- Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535
- and 2 more product lines
Ongoing Class II Medical devices
- Recall started
- 8 May 2020
- Reason
- Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
- Distribution
- US Domestic distribution to CA, FL, and MT. International distribution to AT, AU, DE, ES, FR, JP and SG.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2288-2020
- Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05400-NRF ASK-05500-NRON EJ-054
Terminated Class II Medical devices
- Recall started
- 15 January 2020
- Terminated
- 17 March 2023
- Reason
- There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
- Distribution
- The products were distributed to the following US states: AK, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1181-2020, Z-1179-2020, Z-1200-2020, Z-1204-2020, Z-1202-2020, Z-1196-2020, Z-1171-2020, Z-1175-2020, Z-1195-2020, Z-1206-2020, Z-1215-2020, Z-1205-2020 and 37 more
- Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter, Product Code ASK-05502-NY
- FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1
- EPIDURAL CATHETERIZATION KIT, Product Code IT-05400-DC
- EPIDURAL CATHETERIZATION KIT, Product Code JC-05400-LB
- FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS
- FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Product Code EC-05520-P
- FlexTip Plus Epidural Catheterization Set, Product Code AA-05400-E
- TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1
- and 41 more product lines
Terminated Class II Medical devices
- Recall started
- 20 December 2019
- Terminated
- 25 February 2021
- Reason
- Product lidstock contains the incorrect expiration date for the product
- Distribution
- Nationwide Foreign: AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1241-2020, Z-1239-2020, Z-1254-2020, Z-1236-2020, Z-1243-2020, Z-1242-2020, Z-1237-2020, Z-1246-2020, Z-1251-2020, Z-1238-2020, Z-1249-2020, Z-1253-2020 and 8 more
- Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1
- Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH
- PICC Set- PR-35052-HPHNM
- Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1
- Arrow Central Venous Catheterization Kit ASK-04200-UPM
- Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM
- Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC
- Arrow EPIDURAL CATHETERIZATION KIT YC-02220
- and 12 more product lines
Ongoing Class II Medical devices
- Recall started
- 12 December 2019
- Reason
- The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit
- Distribution
- US distribution to SC
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0844-2020
- Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow¿ Arterial Cathete
Terminated Class II Medical devices
- Recall started
- 6 December 2019
- Terminated
- 2 November 2021
- Reason
- Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH.
- Distribution
- US: FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0837-2020
- Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
Terminated Class II Medical devices
- Recall started
- 15 November 2019
- Terminated
- 19 June 2020
- Reason
- Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death
- Distribution
- U.S. Nationwide, Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0716-2020, Z-0715-2020
- Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
- Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
Terminated Class II Medical devices
- Recall started
- 6 August 2019
- Terminated
- 29 September 2020
- Reason
- Products may contain the incorrect banner card within the kit
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2555-2019, Z-2556-2019
- 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue¿ permits venous acces
- Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of
Terminated Class II Medical devices
- Recall started
- 18 July 2019
- Terminated
- 10 November 2020
- Reason
- Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm in length. The banner card correctly states the product is CDC-42703-1A with a catheter 16cm in length
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0192-2020
- Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits
Terminated Class II Medical devices
- Recall started
- 17 May 2019
- Terminated
- 24 September 2020
- Reason
- Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0053-2020
- Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or condit
Terminated Class II Medical devices
- Recall started
- 23 April 2019
- Terminated
- 13 January 2021
- Reason
- Lidstock states the incorrect expiration date for the product
- Distribution
- Nationwide Foreign:
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1802-2019, Z-1801-2019, Z-1793-2019, Z-1804-2019, Z-1815-2019, Z-1788-2019, Z-1806-2019, Z-1789-2019, Z-1794-2019, Z-1821-2019, Z-1796-2019, Z-1820-2019 and 24 more
- Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Catheter Product Code: CDC 42552 JX1A
- Arrowg+ard Blue Advance JACC Product Code: CDC 42063 JX1A
- Arrow PICC with Chlorag+ard Technology Product Code: CDA 45041 HPK1A
- Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillosubclavian Central Catheter Product Code: CDC 43063 JX1A
- Arrow¿ JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM
- Arrow¿ PICC Kit Product Code: ASK 45541 LVH1
- Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 44052 VPS2
- Arrow PICC Kit Product Code: ASK 45541 RWJ4
- and 28 more product lines
Terminated Class II Medical devices
- Recall started
- 10 January 2019
- Terminated
- 4 June 2020
- Reason
- The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
- Distribution
- FL, NC
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1119-2019, Z-1118-2019
- Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396
- Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
Terminated Class II Medical devices
- Recall started
- 13 December 2018
- Terminated
- 1 October 2020
- Reason
- Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1366-2019, Z-1365-2019
- Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system f
- Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system f
Terminated Class II Medical devices
- Recall started
- 14 November 2018
- Terminated
- 4 June 2020
- Reason
- The lidstock states the incorrect priming volume and flow rates.
- Distribution
- Worldwide distribution: US (nationwide) distribution to state of: FL and to countries of: Argentina, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Ecuador, and Peru.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0723-2019
- Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous acc
Terminated Class II Medical devices
- Recall started
- 2 October 2018
- Terminated
- 12 November 2021
- Reason
- Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.
- Distribution
- Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0940-2019, Z-0953-2019, Z-0945-2019, Z-0946-2019, Z-0955-2019, Z-0954-2019, Z-0956-2019, Z-0943-2019, Z-0948-2019, Z-0952-2019, Z-0951-2019, Z-0944-2019 and 5 more
- AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump
- AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow AutoFuser Disposable Pain Control Pump
- AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump
- AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
- AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
- AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump
- AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
- AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
- and 9 more product lines
Terminated Class II Medical devices
- Recall started
- 21 September 2018
- Terminated
- 23 September 2020
- Reason
- The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is .032 rather than the correct SWG size .025 . For other lots in scope the lidstock correctly states the SWG size .025 however the banner card states the incorrect SWG size .032 .
- Distribution
- US Nationwide distribution in the states of CA, FL, ID, IL, MI, NC, NJ, PA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0468-2019
- Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to the central circula
Terminated Class II Medical devices
- Recall started
- 30 August 2018
- Terminated
- 31 July 2020
- Reason
- The product was shipped after its expiry date due to a system error. The product lidstock identifies the correct expiration date however the accompanying purchase order shipping documentation identifies an incorrect expiration date. Per standard clinical practice the lidstock would most likely be checked prior to use and the product would not be used leading to a minor delay while a replacement is located. In the unlikely event that the product lidstock is not checked prior to use, there is potential for use of expired product, and product functionality/or sterility cannot be guaranteed.
- Distribution
- US nationwide in the states of CA, FL, NC, and RI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0282-2019
- Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous
Terminated Class II Medical devices
- Recall started
- 30 July 2018
- Terminated
- 11 July 2019
- Reason
- Products are labeled with an incorrect expiration date
- Distribution
- US in the state of PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3197-2018
- ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardi
Terminated Class II Medical devices
- Recall started
- 17 July 2018
- Terminated
- 2 December 2020
- Reason
- The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.
- Distribution
- The products were distributed to the following US states: AL, AZ, CA, GA, MA, MD, ME, MI, NY, PA, RI, SC, VA, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3199-2018, Z-3200-2018
- 4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2
- 5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
Terminated Class II Medical devices
- Recall started
- 10 July 2018
- Terminated
- 27 May 2020
- Reason
- The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
- Distribution
- Worldwide Distribution: US (nationwide) to the following states of: AK, AL, CA, FL, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NY, OH, OR, PA, SC, SD, TX, WI, and WV; to countries of:: Finland, Germany, Hungary, Netherlands, South Africa, United Arab Emirates and the United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2819-2018, Z-2818-2018
- HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venous access to the cent
- HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the centr
Terminated Class II Medical devices
- Recall started
- 3 July 2018
- Terminated
- 29 April 2020
- Reason
- One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it contains a 2-lumen, 5 Fr x 8 cm catheter. No patient injuries have been reported related to this issue.
- Distribution
- Distributors in MO and UT. Medical facilities in AL, CA, IL, MA, NH, NM, NY, TX, VA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2886-2018
- Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the central circulation of p
Terminated Class II Medical devices
- Recall started
- 23 May 2018
- Terminated
- 20 May 2020
- Reason
- Product contains dry natural rubber latex. Label states Latex Free.
- Distribution
- Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2576-2018
- Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter in
Terminated Class II Medical devices
- Recall started
- 17 May 2018
- Terminated
- 2 December 2020
- Reason
- Product pouch label may not easily identify the lot number, expiration date and associated symbols..
- Distribution
- US Nationwide Distribution in the states of AR, AZ, CT, FL, GA, IL, IN, KS, KY, MA, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TX, VA & WA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2385-2018, Z-2384-2018, Z-2383-2018, Z-2382-2018
- Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave change
- VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the r
- VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the righ
- VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip
Terminated Class II Medical devices
- Recall started
- 11 May 2018
- Terminated
- 20 April 2020
- Reason
- The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and there may be need of medical intervention by exchanging the catheter for another CVC catheter.
- Distribution
- Distributor in FL. International distribution to Czech Republic, Dominican Republic, France, Greece, and Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2336-2018
- Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by way of the femoral,
Terminated Class II Medical devices
- Recall started
- 11 April 2018
- Terminated
- 15 May 2020
- Reason
- Product sterility may be compromised due to unsealed packaging.
- Distribution
- US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWED
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2006-2018, Z-2009-2018, Z-1967-2018, Z-1988-2018, Z-1975-2018, Z-1989-2018, Z-1977-2018, Z-2021-2018, Z-1963-2018, Z-1997-2018, Z-1994-2018, Z-2003-2018 and 64 more
- 4Fr. Catheter Clamp with Fastener; Product Code: CC-00004
- 8Fr. Catheter Clamp with Fastener; Product Code: CC-00008
- Maximal Barrier Drape; Product Code: ASK-04000-HMC
- Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1
- Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters ; Product Codes: ASK-09903-UM
- ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
- Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product Code: ASK-09907-SB
- Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052
- and 68 more product lines
Terminated Class II Medical devices
- Recall started
- 22 December 2017
- Terminated
- 27 May 2020
- Reason
- Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
- Distribution
- Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1331-2018, Z-1335-2018, Z-1332-2018, Z-1336-2018, Z-1324-2018, Z-1328-2018, Z-1333-2018, Z-1323-2018, Z-1330-2018, Z-1334-2018, Z-1329-2018, Z-1326-2018 and 2 more
- (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterization Kit, PN: ASK-04550
- AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CDC-45854-1A; AGB+ Two
- (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CD
- ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1A
- (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5
- Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A
- ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheterization Kit with Blue FlexTip(R) ARROW
- (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow¿ MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A
- and 6 more product lines
Terminated Class II Medical devices
- Recall started
- 21 December 2017
- Terminated
- 20 April 2020
- Reason
- Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information.
- Distribution
- United States in the state of FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1152-2018
- ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+
Terminated Class II Medical devices
- Recall started
- 15 December 2017
- Terminated
- 18 July 2019
- Reason
- Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.
- Distribution
- Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1194-2018
- ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
Terminated Class II Medical devices
- Recall started
- 27 November 2017
- Terminated
- 22 September 2020
- Reason
- Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
- Distribution
- US in the states of OH, FL, SC, TX, KY, NJ, MI
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1004-2018, Z-1000-2018, Z-0996-2018, Z-0994-2018, Z-1005-2018, Z-1001-2018, Z-0998-2018, Z-1002-2018, Z-0995-2018, Z-0999-2018, Z-1003-2018, Z-0997-2018
- ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring cent
- ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central v
- Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access
- Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment
- ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring centr
- ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous acce
- AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access
- ARROWg+ard Blue Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to
- and 4 more product lines
Terminated Class II Medical devices
- Recall started
- 14 November 2017
- Terminated
- 15 July 2019
- Reason
- Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
- Distribution
- Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1166-2018, Z-1159-2018, Z-1158-2018, Z-1160-2018, Z-1161-2018, Z-1164-2018, Z-1163-2018, Z-1162-2018, Z-1165-2018
- ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation.
- Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access and catheter introduction to the central ci
- Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction
- Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access an
- Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions. Permits venous access to central cir
- Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
- Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access to central circulatio
- Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
- and 1 more product lines
Terminated Class II Medical devices
- Recall started
- 26 October 2017
- Terminated
- 10 December 2019
- Reason
- The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
- Distribution
- US nationwide distribution, including Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1286-2018, Z-1282-2018, Z-1285-2018, Z-1281-2018, Z-1284-2018, Z-1283-2018, Z-1287-2018
- Radial Artery Catheterization Kit; Model: AK-04220
- Radial Artery Catheterization Kit; Model: AK-04020
- Radial Artery Catheterization Kit; Model: AK-04122
- Radial Artery Catheterization Kit; Model: AK-04018
- Radial Artery Catheterization Kit; Model: AK-04120
- Radial Artery Catheterization Kit; Model: AK-04020-C
- Arterial Access Tray, introducer catheter; Model: GU-04020
Terminated Class II Medical devices
- Recall started
- 24 October 2017
- Terminated
- 17 April 2020
- Reason
- Product packaging may not be completely sealed.
- Distribution
- Nationally
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1299-2018, Z-1297-2018, Z-1298-2018
- Pneumothorax Kit
- Large Volume Abdominal Paracentesis Kit
- ArrowClarke" PleuraSeal¿ Thoracentesis Kit
Terminated Class II Medical devices
- Recall started
- 17 October 2017
- Terminated
- 14 April 2020
- Reason
- These finished good kits may contain the incorrect Springwire Guide (SWG).
- Distribution
- Distribution US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0651-2018, Z-0656-2018, Z-0654-2018, Z-0658-2018, Z-0650-2018, Z-0657-2018, Z-0652-2018, Z-0647-2018, Z-0648-2018, Z-0653-2018, Z-0655-2018, Z-0649-2018
- Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK-15703-PRWJ; Exp. Dates Feb 2018- Nov 2018
- ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018
- Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
- ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2018
- Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
- Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
- Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dates Feb 2018 - Nov 2018
- Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 2018 - Nov 2018
- and 4 more product lines
Terminated Class II Medical devices
- Recall started
- 17 October 2017
- Terminated
- 21 April 2020
- Reason
- The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter.
- Distribution
- AZ, CA, GA, MA, MO, NY, VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0690-2018
- ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet
Terminated Class II Medical devices
- Recall started
- 25 July 2017
- Terminated
- 29 August 2018
- Reason
- Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0601-2018, Z-0602-2018
- ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
- ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.
Terminated Class II Medical devices
- Recall started
- 10 July 2017
- Terminated
- 14 September 2018
- Reason
- Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
- Distribution
- ...
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0486-2018
- Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
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.