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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 Device Recall BD 30ml Syringe Luer Lok Tip see related information
Date Initiated by Firm November 23, 2009
Date Posted December 29, 2009
Recall Status1 Terminated 3 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 NJ 07417-1815
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
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 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.
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