Williamston, MI, United States
Centurion Medical Products Corporation recalls
12 recalls recorded since 2018, most recently on 11 December 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls12
Ongoing (FDA)0
Terminated or completed12
Class I (FDA)1
Terminated Class II Medical devices
- Recall started
- 11 December 2019
- Terminated
- 4 September 2020
- Reason
- Incomplete seals on the sterile package may compromise the sterility
- Distribution
- Nationwide Foreign: GHANA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1058-2020, Z-1091-2020, Z-1080-2020, Z-1090-2020, Z-1047-2020, Z-1070-2020, Z-1043-2020, Z-1071-2020, Z-1059-2020, Z-1088-2020, Z-1072-2020, Z-1085-2020 and 42 more
- Centurion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170 UMBILICAL VESSEL TRAY W/O CATHETER UVT280 UMBILICAL ARTERY TRAY UVT460 UMBILICAL CATHETER TRAY
- Centurion- ENT SNUF3 SNUFFER KIT Y
- Centurion- HT5555A HYPERALIMENTATION & DRSG CHG TRAY
- Centurion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY
- Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPARATION PACK DT10415 PICC INSERTION TRAY DT10495 PICC INSERTION TRAY DT10525 CENTRAL LINE INSERTION DRAPE KIT DT10675
- Centurion- Biopsy Tray TRIBT170 BIOPSY TRAY
- Centurion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY CHT1700 CHEST TUBE INSERTION TRAY CHT1760 CHEST TRAY CHT275 CHEST TUBE INSERTION TRAY CHT440 CHEST TUBE INSERTION TR
- Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM
- and 46 more product lines
Terminated Class II Medical devices
- Recall started
- 24 October 2019
- Terminated
- 24 June 2020
- Reason
- Sterile packaging incomplete seals may compromise sterility of the product
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0344-2020
- Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955
Terminated Class II Medical devices
- Recall started
- 28 August 2019
- Terminated
- 23 July 2020
- Reason
- A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0121-2020, Z-0120-2020
- Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 330CR
- Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR
Terminated Class II Medical devices
- Recall started
- 15 July 2019
- Terminated
- 31 August 2020
- Reason
- Supplier initiated recall of the GRIPPER Needles
- Distribution
- IL
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0256-2020, Z-0254-2020, Z-0255-2020, Z-0253-2020
- PORT ACCESS INFUSION KIT - 1" NEEDLE Product Code: DYNDC2817
- Maintenance Flush Kit/Blood Draw Product Code: DT19335
- Kit, Port Access Product Code: DYNDC1582A
- Port full Access Tray Product Code: DT19330
Terminated Class II Medical devices
- Recall started
- 1 July 2019
- Terminated
- 26 June 2020
- Reason
- Potential for sterile packaging to be compromised
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2170-2019, Z-2167-2019, Z-2163-2019, Z-2161-2019, Z-2172-2019, Z-2173-2019, Z-2171-2019, Z-2169-2019, Z-2165-2019, Z-2166-2019, Z-2168-2019, Z-2164-2019 and 1 more
- DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
- DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
- CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performing circumcision procedures on newborns.
- STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facilitate examination. It is used by medical professionals in a clinical setting.
- LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceration repairs for general population.
- SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for laceration repairs for general population.
- UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional anesthesia nerve blocks for general population.
- DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
- and 5 more product lines
Terminated Class II Medical devices
- Recall started
- 24 June 2019
- Terminated
- 24 July 2020
- Reason
- Various medical device kits contain MAJOR Nasal Decongestant Spray is being recalled by the manufacturer.
- Distribution
- CT, IL
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0409-2020, Z-0407-2020, Z-0408-2020
- NOSEBLEED TRAY Kit Code: MNS3885
- EPISTAXIS TRAY Kit Code: MNS10165
- YNHH SCOPE KIT Kit Code: MNS10475
Terminated Class I Medical devices
- Recall started
- 7 June 2019
- Terminated
- 28 July 2020
- Reason
- Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan connector becoming disconnected from Endotracheal Tube.
- Distribution
- Distributed to one account in Arkansas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1956-2019
- Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
Terminated Class II Medical devices
- Recall started
- 1 June 2019
- Terminated
- 21 June 2021
- Reason
- False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutainer¿ Plastic Lithium Heparin tubes with the IL GEM 4000 instrument.
- Distribution
- US Nationwide distribution including in the state of IL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2545-2020
- Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 367960; Centurion code 45177 (VACUTAINER GREEN TOP) and 84815 (VACUTAINER 3ML LT. GREEN). Centurion K
Terminated Class II Medical devices
- Recall started
- 24 April 2019
- Terminated
- 3 April 2020
- Reason
- Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
- Distribution
- Nationwide domestic distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0077-2020, Z-0100-2020, Z-0075-2020, Z-0078-2020, Z-0082-2020, Z-0091-2020, Z-0081-2020, Z-0093-2020, Z-0096-2020, Z-0079-2020, Z-0095-2020, Z-0094-2020 and 21 more
- PEDIATRIC PICC INSERTION TRAY CVI4450A
- OR VANTEX 7FR 3L 16CM CVC ECVC6665
- PICC Line Accessory Kit CVI4285
- NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535
- Neonatal Cap Change Kit DT20315
- CVC BUNDLE, 20CM, 3L, PI ECVC5120
- Cap Change Kit DT20310
- CVC BUNDLE MULTIMED, 3L, 20CM ECVC6060
- and 25 more product lines
Terminated Class II Medical devices
- Recall started
- 29 March 2019
- Terminated
- 8 May 2020
- Reason
- Compromised seal on the sterile barrier pouch.
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1719-2019, Z-1720-2019
- Sterile Nail Clipper Concave Edge (67710)
- Sterile Nail Nipper, Barrel Spring (I68400), Sterile
Terminated Class II Medical devices
- Recall started
- 23 October 2017
- Terminated
- 21 June 2018
- Reason
- Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
- Distribution
- Nationally
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1090-2018, Z-1080-2018, Z-1079-2018, Z-1091-2018, Z-1083-2018, Z-1095-2018, Z-1093-2018, Z-1094-2018, Z-1081-2018, Z-1085-2018, Z-1089-2018, Z-1087-2018 and 9 more
- NEONATAL IV ACCESS SET
- GENERAL PURPOSE INSTRUMENT TRAY
- SUTURE REMOVAL TRAY, SET or KIT
- LATEX FREE IV START SET
- CATHETER SECUREMENT SYSTEM
- NEONATAL IV START KIT
- IV START KIT
- INFANT IV SECUREMENT KIT
- and 13 more product lines
Terminated Class II Medical devices
- Recall started
- 5 July 2017
- Terminated
- 9 March 2018
- Reason
- Centurion is recalling specific lots of convenience kits, SafetyGlide Needle, 22GA 1-1/2in, manufactured by BD, sold in Centurion Convenience Kits. distributed between May 2016 and June 2017 due to notice received from BD's recall due to particulate that could be expelled out of the needle if used for injection.
- Distribution
- US.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0315-2018
- SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.
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.