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U.S. Department of Health and Human Services

Class 2 Device Recall BD 60 ml Syringe LuerLok Tip

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  Class 2 Device Recall BD 60 ml Syringe LuerLok Tip see related information
Date Initiated by Firm July 15, 2008
Date Posted September 18, 2008
Recall Status1 Terminated 3 on April 16, 2009
Recall Number Z-2374-2008
Recall Event ID 49015
Product Classification Syringe - Product Code FMF
Product BD 60 ml Syringe, Luer-Lok Tip
Sterile;
Cases : 160 (4 x 40)
Shelf Carton: 40
BD; Franklin Lakes, NJ 07417 USA. Made in USA.

Syringes for use in aspiration and injection of medications.
Code Information Reorder Number: 309653; Lot numbers beginning with the numbers 5, 6, or 7 and also the following lot numbers. 8010954, 8014571, 8031115, 8031117, 8031119, 8031124, 8031133, 8038154, 8038158, 8045564, 8045567, 8058890, 8058896, 8058898, 8058900, 8058902, 8072401, 8072409, 8072414, 8072419, 8079645, and 8079656.  Note: In order to make the recall practical for customers to implement, BD has requested the return of lots beginning with the numbers 5,6 or 7. while not all lots beginning with the digits 5,6 and 7 exhibit the issue, it is much easier to instruct customers to return these lots, rather than have customrs examine/check a more comprehensive list of affected and unaffected lots.
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		 Becton Dickinson identified the presence of open seals during an internal inspection process.
FDA Determined
Cause 2		 Package design/selection
Action Urgent: Product Recall letters were sent to Distributors and Syringe Customers on July 15, 2008 by UPS second day air. Customers are to immediately review their inventory, determine if they have any affected product, and remove the affected if they have any. Next customers should complete the enclosed Customer Packing List and BD will send a replacement product upon receipt of the returned product. Questions are to be directed to BD Customer Service at 1-888-237-2762, M-F, 8:00 AM to 5:00 PM EST.
Quantity in Commerce 1246 lots
Distribution Nationwide Distribution.
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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