FDA-Device2023-09-20Class I
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Mallinckrodt Manufacturing LLC
Hazard
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
Sold states
Worldwide Distribution
Affected count
13,602 units
Manufactured in
6603 Femrite Dr, Madison, WI, United States
Products
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2450-2023Don't want to check this manually?
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