Date Initiated by Firm | June 01, 2019 |
Create Date | July 09, 2020 |
Recall Status1 |
Terminated 3 on June 21, 2021 |
Recall Number | Z-2545-2020 |
Recall Event ID |
85494 |
Product Classification |
Tubes, vials, systems, serum separators, blood collection - Product Code JKA
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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 |
Code Information |
Lot Number: 2019050790 exp. Date: 10/31/2019 |
Recalling Firm/ Manufacturer |
Centurion Medical Products Corporation 100 Centurion Way Williamston MI 48895-9086
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For Additional Information Contact | Lisa A. Carpenter 517-546-5400 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 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. |
Quantity in Commerce | 140 units |
Distribution | US Nationwide distribution including in the state of IL. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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