Recall Z-0508-2021 ยท FMI Needle, Hypodermic, Single Lumen
Becton Dickinson & Company
BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number: 320122
| Date | Oct 23, 2020 |
| Status | Terminated |
| Reason | Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information pertinent to users in the US regarding compatibility with specific pen needles is missing. |
| Root cause | Under Investigation by firm |
| Action | BD consignees and distributors notified on October 23, 2020 via hard copy letter sent via Federal Express (FedEx) and/or email, when available. Letter states reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific Catalog (Ref) and Lot number specified in this notification and discard all product subject to the recall. 2. Share this recall notification with pharmacy staff at all applicable pharmacy locations and display the letter where it is visible to all to ensure awareness of this recall Distributors are requested to identify their customer |
| Quantity | 2,881,200 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162516 | BD Pen Needle Becton, Dickinson and Company, Dec 9, 2016 |