—#181092

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

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected lot / code info: Lot Number: 2019050790 exp. Date: 10/31/2019

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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 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.

Recalling firm

Firm: Centurion Medical Products Corporation
Address: 100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern: US Nationwide distribution including in the state of IL.

Timeline

Recall initiated: 2019-06-01
Terminated: 2021-06-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181092. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.