Recall Z-2192-2011 ยท FMI Needle, Hypodermic, Single Lumen
Becton Dickinson & Company
BD Nokor Admix Needle 16 G x 1 TW (1.6mm x 25mm) REF 305216 Sterile BD, Franklin Lakes, NJ MADE IN USA For use in aspiration of medications, typically in the pharmacy setting.
| Date | May 13, 2011 (initiated Mar 1, 2011) |
| Status | Terminated |
| Reason | Incorrect unit package labels which reflect Reorder #305216 instead of the correct item, Reorder #305213, were used. |
| Root cause | Packaging |
| Action | BD sent an Urgent: Product Recall letter with return response forms to direct consignees on 03/01/11 and 03/02/11 via UPS. The letter identified the affected product and lot along with the reason for the recall. The letter asked customers to complete the enclosed Distributor Packing List and to follow the instructions provided on the Packing List for returning the affected product. The firm will issue a credit upon receipt of the affected product. Customers can contact BD Customer Service if they need assistance or have questions regarding the recall. |
| Quantity | 161,000 units |
| Distribution | Worldwide Distribution -- USA, including the states of NJ, IL, LA, NM, OH, NV, and VA, and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.