Recall Z-0110-2024 ยท MDB System, Blood Culturing
Becton Dickinson & Co.
BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023
| Date | Oct 12, 2023 (initiated Sep 12, 2023) |
| Status | Open, Classified |
| Reason | Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial. |
| Root cause | Under Investigation by firm |
| Action | An URGENT: Medical Device Product Correction notification letter dated 9/12/23 was sent to customers. Please Take the Following Actions: 1. Immediately inspect your inventory for the specific catalog and lot numbers listed above to determine if the BD BACTEC" Plus Aerobic/F Culture Vials in your possession are impacted. 2. Ensure the contents of this Product Advisory are read and understood. 3. Share and post this recall letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 4. Users should verify that the accession n |
| Quantity | 781,600 vials |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113558 | BD BACTEC Plus Aerobic/F Culture Vials (plastic) Becton, Dickinson and Company, Mar 16, 2012 |