—#86845

Product

BD 30 ml Syringe; Luer-Lok Tip Catalog # 309650 Becton Dickinson, Franklin Lakes, NJ.

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Catalog Number: 309650; Lot number 9175046

Why it was recalled

Reports received of open seals on lot # 9175046, BD 30 ml Luer-Lok Syringes. This indicates product sterility may be compromised.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Distributors nationwide.

Timeline

Recall initiated: 2009-11-23
Posted by FDA: 2009-12-29
Terminated: 2010-04-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86845. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.