Recall Z-2450-2023— Mallinckrodt Manufacturing LLC
Class I · Ongoing
Class I FDA medical device recall by Mallinckrodt Manufacturing LLC, initiated 2023-08-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.. Reason: The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen..
- Recalling firm
- Mallinckrodt Manufacturing LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-08-08
- Firm location
- Madison, WI, United States
Product description
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Reason for recall
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
Data sourced from openFDA. This site is unofficial and independent of the FDA.