Mallinckrodt One-Way Valve recall
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Why was Mallinckrodt One-Way Valve recalled?
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) UDI/DI 10810055283460, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237; b) UDI/DI 10810055283467, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237
- Product
- Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
- Recalling firm
- Mallinckrodt Manufacturing LLC
- Quantity
- 13,602 units
- Distribution
- Worldwide Distribution
- Recall date
- September 20, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)