Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
This recall is currently active, issued September 9, 2023. It was issued by Mallinckrodt Manufacturing Llc.
- Company
- Mallinckrodt Manufacturing Llc
- Recall Initiated
- August 8, 2023
- Posted
- September 9, 2023
- Recall Number
- Z-2450-2023
- Quantity
- 13,602 units
- Firm Location
- Madison, WI
- Official Source
- View on FDA website ↗
Reason for Recall
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
Distribution
Worldwide Distribution
Lot / Code Info
a) UDI/DI 10810055283460, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237; b) UDI/DI 10810055283467, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237
Root Cause
Under Investigation by firm
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.