Recall Z-2545-2020— Centurion Medical Products Corporation
Class II · Terminated
Class II FDA medical device recall by Centurion Medical Products Corporation, initiated 2019-06-01, terminated 2021-06-21. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutainer¿ Plastic Lithium Heparin tubes with the IL GEM 4000 instrument..
- Recalling firm
- Centurion Medical Products Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-06-01
- Terminated
- 2021-06-21
- Firm location
- Williamston, MI, United States
Product description
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
Reason for recall
False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutainer¿ Plastic Lithium Heparin tubes with the IL GEM 4000 instrument.
Data sourced from openFDA. This site is unofficial and independent of the FDA.