Recall Z-2424-2024 ยท FMI Needle, Hypodermic, Single Lumen
Embecta Corp.
BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector Model/Catalog Number: 320551
| Date | Jul 23, 2024 (initiated Jun 18, 2024) |
| Status | Open, Classified |
| Reason | BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cannot be guaranteed. |
| Root cause | Process control |
| Action | embecta* issued Urgent Medical Device Recall Letter on 6/18/24 via Fed'X to Pharmacist & Pharmacy Staff and End Users. Letter states reason for recall, health risk and action to take: 1. Review your product to see if it matches the specific Catalog (Ref) and Lot number listed above. Immediately discard all unused product into a sharps container. 2. If the affected product was previously used, follow up with a healthcare professional if there are any adverse reactions such as inflammation or redness of the skin. 3. Complete the online Customer Response Form whether or not you have any of the i |
| Quantity | 185900 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212015 | BD Nano 2nd Gen Pen Needle Becton, Dickinson and Company, Nov 19, 2021 |