Mallinckrodt One-Way Valve Recalled Due to Potential Oxygen Flow Failure
Mallinckrodt Manufacturing is recalling approximately 13,600 One-Way Valves used with ventilators due to risk of valve sticking and oxygen flow reduction. The Class I recall affects worldwide distribution.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a critical respiratory support device. Although no illnesses or injuries have been reported, the valve malfunction directly threatens oxygen delivery to mechanically ventilated patients, and the FDA's Class I designation reflects a reasonable probability of serious injury or death.
Plain-English summary
Mallinckrodt Manufacturing LLC is recalling approximately 13,602 One-Way Valves, model 22F x 22M, designed for use with ventilators. The recall involves Part #91346 (individual unit) and Part #50412 (5-pack), identified by specific lot codes and UDI codes.
The One-Way Valve may stick internally and prevent or reduce the flow of ventilated air or oxygen. This malfunction could compromise the delivery of respiratory support to patients requiring mechanical ventilation.
The affected devices have been distributed worldwide. Healthcare facilities and individuals using these valves should immediately verify whether they possess any of the affected lot codes or UDI numbers.
The recalled product
- Product
- Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
- Manufacturer
- Mallinckrodt Manufacturing LLC
- Hazard
- stuck-valve
- reduced-oxygen-flow
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- a) UDI/DI 10810055283460
- Lot Codes: 74L2001714
- 74L2001715
- 74L2001716
- 74M2001125
- 74B2100237
- b) UDI/DI 10810055283467
Distribution
Distribution scope not specified by the agency.
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