Device product
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Z-2450-2023
Product summary
- Event
- Event 92799
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 13,602 units
- Official record key
device-enforcement:Z-2450-2023
Official wording
Reason: The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
Code information: a) UDI/DI 10810055283460, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237; b) UDI/DI 10810055283467, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237
Distribution pattern: Worldwide Distribution
Derived failure modes
-
Unknown
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.