Device product
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
Z-2545-2020
Product summary
- Event
- Event 85494
- Status
- Terminated
- Classification
- Class II
- Quantity
- 140 units
- Official record key
device-enforcement:Z-2545-2020
Official wording
Reason: False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutainer¿ Plastic Lithium Heparin tubes with the IL GEM 4000 instrument.
Code information: Lot Number: 2019050790 exp. Date: 10/31/2019
Distribution pattern: US Nationwide distribution including in the state of IL.
Derived failure modes
-
Unknown
False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutainer¿ Plastic Lithium Heparin tubes with the IL GEM 4000 instrument.