Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2374-2008

BD 60 ml Syringe, Luer-Lok Tip Sterile; Cases : 160 (4 x 40) Shelf Carton: 40 BD; Franklin Lakes, NJ 07417...

Becton Dickinson & Co / initiated 2008-07-15 / Terminated / root cause: packaging

Becton Dickinson & Company began a recall of 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... on . The reason FDA records is "Becton Dickinson identified the presence of open seals during an internal inspection process". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-2374-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
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.
Product code
FMF Syringe, Piston
Reason for recall
Becton Dickinson identified the presence of open seals during an internal inspection process.
Root cause tag
packaging
FDA root cause
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.
Product codes and lots
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.