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U.S. Department of Health and Human Services

Class 2 Device Recall Becton Dickinson

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  Class 2 Device Recall Becton Dickinson see related information
Date Initiated by Firm April 09, 2007
Date Posted May 24, 2007
Recall Status1 Terminated 3 on August 09, 2007
Recall Number Z-0813-2007
Recall Event ID 37871
510(K)Number K980987  
Product Classification syringe - Product Code FMF
Product BD 5ml Syringe Luer-Lok Tip
Bulk Sterile Convenience Pak
Latex Free
Code Information Lot number 7002604 Ref 309703
Recalling Firm/
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Greg Morgan
Manufacturer Reason
for Recall
Small cracks in plastic trays of one lot of BD 5mL Syringe Luer Lok Tip, Bulk Sterile Convenience Paks that may adversely affect tray integrity and steriity.
FDA Determined
Cause 2
Action Recall communications were sent on April 2, 2007 and May 3, 2007 by UPS second day air to all direct consignees and potential customers.
Quantity in Commerce 174,300 units
Distribution 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 = FMF and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC