—#83442

Product

BD 60ml Syringe Luer-Lok tip, Sterile, BD, Franklin Lakes, NJ 07417, Made in USA.

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Product Number: 309653; Lot Number: 819101A.

Why it was recalled

Insufficient Seal: Becton Dickinson received complaints of insufficient/open seals on one lot of 60 ml Luer-Lok Syringes.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- Including states of IL, CA, VA, PA, and FL.

Timeline

Recall initiated: 2009-07-07
Posted by FDA: 2009-08-12
Terminated: 2009-10-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83442. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.