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U.S. Department of Health and Human Services

Class 2 Device Recall BD 30ml Syringe Luer Lok Tip

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 Class 2 Recall
BD 30ml Syringe Luer Lok Tip
see related information
Date Posted December 29, 2009
Recall Status1 Terminated on April 06, 2010
Recall Number Z-0586-2010
Recall Event ID 53901
Product Classification Syringe, Piston - Product Code FMF
Product BD 30 ml Syringe; Luer-Lok Tip Catalog # 309650 Becton Dickinson, Franklin Lakes, NJ.
Code Information Catalog Number: 309650; Lot number 9175046
Recalling Firm/
Manufacturer
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes, New Jersey 07417-1815
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Greg Morgan
201-847-4344
Manufacturer Reason
for Recall
Reports received of open seals on lot # 9175046, BD 30 ml Luer-Lok Syringes. This indicates product sterility may be compromised.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Recall notification letters were sent to all distributors on 11/23/2009 by Federal Express. BD called all distributors to get customer lists and will start sending letter to customers commencing on December 8, 2009. Questions are directed to BD Customer Service at 1-888-237-2762, Monday  Friday, 8:00 AM  5:00 PM Eastern Time.
Quantity in Commerce 166240 units
Distribution Distributors 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
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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