Mallinckrodt Manufacturing LLC recalls Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
- Recall date
- August 8, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2450-2023
- FDA classification
- Class I
- Brand / firm
- Mallinckrodt Manufacturing LLC
- Sold / distributed
- Worldwide Distribution
Why it was recalled
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
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