—#67217

Product

BD 5 ml Syringe Luer Lok Tip Bulk Sterile Convenience Pak. Latex Free . Sterile. Reorder Number: 309703, BD, Franklin Lakes, NJ 07417.

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Reorder # 309703: Lot numbers: 7123237, 7156175, 7156177, 7212946, 7212948, 7239565, 7239566, 7271878.

Why it was recalled

Defective Seal: The convenience trays may have open seals, which can adversely impact tray sterility.

Root cause (FDA determination)

Packaging

Action the firm took

BD notified distributors by an Urgent Product Recall Letter sent via UPS on January 7, 2008. In addition, the firm sent an Urgent Product Recall Letter on January 11, 2008 to customers identified by the distributors. The letter instructed the users to remove the product from its inventory and to return affected products to the firm using an enclosed customer packing list. For additional information, contact 1-888-237-2762.

Recalling firm

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

Distribution

Distribution pattern: Nationwide, including the states of CA, NY, MO, MA, IL, OH, TN, TX, MI, LA, MO, ID, GA, NE, SC and FL.

Timeline

Recall initiated: 2008-01-07
Posted by FDA: 2008-04-16
Terminated: 2008-05-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67217. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.