Recall Z-0914-2008 ยท FMF Syringe, Piston
Becton Dickinson & Company
BD 5 ml Syringe Luer Lok Tip Bulk Sterile Convenience Pak. Latex Free . Sterile. Reorder Number: 309703, BD, Franklin Lakes, NJ 07417.
| Date | Apr 16, 2008 (initiated Jan 7, 2008) |
| Status | Terminated |
| Reason | Defective Seal: The convenience trays may have open seals, which can adversely impact tray sterility. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.