Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
FDA device recall Z-2450-2023 · posted 2023-09-09 · Open, Classified
Recall details
- Recalling firm
- Mallinckrodt Manufacturing LLC
- Reason for recall
- The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- BZO
- Quantity affected
- 13,602 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2023-08-08
- Date posted
- 2023-09-09
- Location
- Madison, WI
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