FDA Device recall Z-2450-2023
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators
- FDA Device
- Class I
- ongoing
- Published 2023-09-20
On 2023-09-20 the FDA classified a Class I recall of Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators by Mallinckrodt Manufacturing, citing the One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2450-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-08-08 |
| Published | 2023-09-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Mallinckrodt Manufacturing |
| Distribution | n/a |
Product
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Reason
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
Identifiers
| code_info | a) UDI/DI 10810055283460, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237; b) UDI/DI 1081005528…a) UDI/DI 10810055283460, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237; b) UDI/DI 10810055283467, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2450-2023%22
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