Recall Z-2545-2020 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Centurion Medical Products Corporation
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 Kit Code: IV8860
| Date | Jun 1, 2019 |
| Status | Terminated |
| Reason | False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutainer Plastic Lithium Heparin tubes with the IL GEM 4000 instrument. |
| Root cause | Device Design |
| Action | Centurion Notification issued to parent company, Medline Industries, via email to Recall Team via their Corporate Headquarters on 6/18/19. Letter states reason for recall, health risk and Required Action: 1. Whether or not you have product in inventory, please complete and return the attached Accountability Record via email - lcarpenter@centurionmp.com or via fax -517-546-3356. 2. Please forward the BD notice to any customer(s) that may receive these kits. 3. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWat |
| Quantity | 140 units |
| Distribution | US Nationwide distribution including in the state of IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.