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
FDA Recall Z-2545-2020 · Posted None
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Recalling FirmCenturion Medical Products Corporation
Recall StatusTerminated
Product CodeJKA
Date Initiated2019-06-01
Date Terminated2021-06-21
Product Quantity140 units
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.
Firm 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 - [email protected] 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 MedWatch Adverse Event Reporting program.
Contact BO at 1-888-237-2762, (select Option #3 and then Option #2),
between 8AM and 5PM CT Monday through Friday.
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution including in the state of IL.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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