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U.S. Department of Health and Human Services

Class 2 Device Recall Becton Dickinson

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 Class 2 Recall
Becton Dickinson
see related information
Date Posted May 24, 2007
Recall Status1 Terminated on August 09, 2007
Recall Number Z-0813-2007
Recall Event ID 37871
Premarket Notification
510(K) Number
K980987 
Product Classification Syringe, Piston - 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/
Manufacturer
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes, New Jersey 07417-1815
For Additional Information Contact Greg Morgan
210-847-4344
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.
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 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
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