Recall Z-1811-2009 ยท FMF Syringe, Piston
Becton Dickinson & Company
BD 60ml Syringe Luer-Lok tip, Sterile, BD, Franklin Lakes, NJ 07417, Made in USA.
| Date | Aug 12, 2009 (initiated Jul 7, 2009) |
| Status | Terminated |
| Reason | Insufficient Seal: Becton Dickinson received complaints of insufficient/open seals on one lot of 60 ml Luer-Lok Syringes. |
| Root cause | Packaging process control |
| Action | 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. |
| Quantity | 133,600 units |
| Distribution | Nationwide Distribution -- Including states of IL, CA, VA, PA, and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.