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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer Blood Collection Tubes

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  Class 2 Device Recall BD Vacutainer Blood Collection Tubes see related information
Date Initiated by Firm June 12, 2019
Create Date August 21, 2019
Recall Status1 Terminated 3 on June 29, 2020
Recall Number Z-2301-2019
Recall Event ID 82963
510(K)Number K945952  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960
Code Information UDI: (01)30382903679608
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Customer Quality
888-237-2762
Manufacturer Reason
for Recall		 False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
FDA Determined
Cause 2		 Device Design
Action Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers.
Quantity in Commerce 1,436,228,004 total
Distribution Worldwide Distribution, including US Nationwide
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = JKA and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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