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U.S. Department of Health and Human Services

Class 3 Device Recall Microtainer

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  Class 3 Device Recall Microtainer see related information
Date Initiated by Firm October 16, 2002
Date Posted January 16, 2003
Recall Status1 Terminated 3 on April 15, 2004
Recall Number Z-0447-03
Recall Event ID 25170
510(K)Number K940905  
Product Classification Tubes, Vials, Systems, Serum Separators, Blood Collection - Product Code JKA
Product Microtainer Brand Tube with EDTA (K2), Catalog Number 365974.
Code Information Lot #2098765
Recalling Firm/
Manufacturer
Becton Dickinson & Company
1 Becton Drive
Franklin Lakes NJ 07417
For Additional Information Contact Kevin Nolan
201-847-5651
Manufacturer Reason
for Recall
Insufficient amount of EDTA found within the tube causing clotting and erroneous platelet counts.
FDA Determined
Cause 2
Other
Action Becton Dickinson contacted their Distributors and customers with return instructions via certified mail on or about Oct. 16, 2002.
Quantity in Commerce 141600
Distribution The firm distributed this product nationwide to wholesalers and direct customers.
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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