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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.
Recalled September 20, 2023 · FDA recall Z-2450-2023 · Mallinckrodt Manufacturing
Hazard
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen. · FDA Class I
Units
13,602 units
Sold at
Worldwide Distribution
Description
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
Product
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Manufacturer(s)
Mallinckrodt Manufacturing LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →