Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0914-2008

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

Becton Dickinson & Co / initiated 2008-01-07 / Terminated / root cause: packaging

Becton Dickinson & Company began a recall of BD 5 ml Syringe Luer Lok Tip Bulk Sterile Convenience Pak. Latex Free . Sterile. Reorder Number: 309703, BD, Franklin Lakes, NJ 07417 on . The reason FDA records is "Defective Seal: The convenience trays may have open seals, which can adversely impact tray sterility". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-0914-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
BD 5 ml Syringe Luer Lok Tip Bulk Sterile Convenience Pak. Latex Free . Sterile. Reorder Number: 309703, BD, Franklin Lakes, NJ 07417.
Product code
FMF Syringe, Piston
Reason for recall
Defective Seal: The convenience trays may have open seals, which can adversely impact tray sterility.
Root cause tag
packaging
FDA root cause
Packaging
Action
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.
Quantity in commerce
1,754,100
Distribution
Nationwide, including the states of CA, NY, MO, MA, IL, OH, TN, TX, MI, LA, MO, ID, GA, NE, SC and FL.
Product codes and lots
Reorder # 309703: Lot numbers: 7123237, 7156175, 7156177, 7212946, 7212948, 7239565, 7239566, 7271878.