Class 3 Device Recall Microtainer

• Date Initiated by Firm: October 16, 2002
• Date Posted: January 16, 2003
• Recall Status: Terminated 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: 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