Recall Z-2450-2023 ยท BZO Set, Tubing And Support, Ventilator (W Harness)
Mallinckrodt Manufacturing LLC
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
| Date | Sep 9, 2023 (initiated Aug 8, 2023) |
| Status | Open, Classified |
| Reason | The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen. |
| Root cause | Under Investigation by firm |
| Action | Mallinckrodt Pharmaceuticals issued an URGENT: MEDICAL DEVICE RECALL NOTICE to its consignees on 08/08/2023 via FedEx. the notice explained the issue, risks associated with the failure, and requested the return of the device. |
| Quantity | 13,602 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.