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U.S. Department of Health and Human Services

Class 2 Device Recall BD 60ml Syringe LuerLok tip

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  Class 2 Device Recall BD 60ml Syringe LuerLok tip see related information
Date Initiated by Firm July 07, 2009
Date Posted August 12, 2009
Recall Status1 Terminated 3 on October 02, 2009
Recall Number Z-1811-2009
Recall Event ID 52601
Product Classification Syringe, piston - Product Code FMF
Product BD 60ml Syringe Luer-Lok tip, Sterile, BD, Franklin Lakes, NJ 07417, Made in USA.
Code Information Product Number: 309653; Lot Number: 819101A.
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		 Insufficient Seal: Becton Dickinson received complaints of insufficient/open seals on one lot of 60 ml Luer-Lok Syringes.
FDA Determined
Cause 2		 Packaging process control
Action Becton Dickinson issued an "Urgent: Product Recall" notice via UPS tracking dated July 7, 2009 to all distributors informing them of the affected product. The firm asked all distributors to identify end customers in an attempt to notify all customers. The firms asks that all affected product be returned. Further questions should be directed to BD Customer Service representatives at 1-888-237-2762.
Quantity in Commerce 133,600 units
Distribution Nationwide Distribution -- Including states of IL, CA, VA, PA, and FL.
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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