—#72525

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.

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: 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.

Why it was recalled

Becton Dickinson identified the presence of open seals during an internal inspection process.

Root cause (FDA determination)

Package design/selection

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2008-07-15
Posted by FDA: 2008-09-18
Terminated: 2009-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72525. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.