Reported Sep 20, 2023 · Ongoing
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
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mallinckrodt Manufacturing LLC · 6603 Femrite Dr · Madison, WI · 53718-6801
Is this the product you have?
- Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
- Lot codes and dates
- a) UDI/DI 10810055283460
- Lot Codes
74L200171474L200171574L200171674M200112574B2100237b) UDI/DI 10810055283467
- Lot Codes
74L200171474L200171574L200171674M200112574B2100237
- Amount recalled
- 13,602 units
Why it was recalled
Stop using this product now
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
Using this product could cause serious injury, illness or death — stop using it now.
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