Recall Z-1109-2021 ยท FMF Syringe, Piston
Becton Dickinson & Company
BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482
| Date | Dec 23, 2020 |
| Status | Terminated |
| Reason | The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe. |
| Root cause | Process control |
| Action | On 01/13/2020 BD issued an Urgent Medical Device Recall notices to distributors via letters and via e-mail. Distributors are requested to identify their customers and provide BD a customer list so that BD can undertake further communication to the users. BD will distribute the recall communication to the distributors customers via FedEx upon receiving the customer information from the distributors. A copy of the BD product recall customer letter will be provided to distributors, in the case they opt to contact their customers directly. |
| Quantity | 155,200 needles |
| Distribution | Distribution US nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980987 | BECTON DICKINSON SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic, Jun 11, 1998 |