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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion DIFFICULT IV KIT

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 Class 2 Device Recall Centurion DIFFICULT IV KITsee related information
Date Initiated by FirmJune 01, 2019
Create DateJuly 09, 2020
Recall Status1 Terminated 3 on June 21, 2021
Recall NumberZ-2545-2020
Recall Event ID 85494
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
ProductCenturion 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
For Additional Information ContactLisa 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
ActionCenturion 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 Commerce140 units
DistributionUS Nationwide distribution including in the state of IL.
Total Product Life CycleTPLC Device Report

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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