FDAAugust 8, 2023device

Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.

What to do

FDA enforcement status: Ongoing

Brands named

mallinckrodt manufacturingmallinckrodt

UPCs

1081005528346010810055283467

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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