CLASS I ONGOING Device recall · Reported 20 Sep 2023 · FDA Enforcement Report
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 recalled
Mallinckrodt Manufacturing is recalling Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack. The recall was initiated on 8 Aug 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2450-2023
- FDA event ID
- 92799
- Recalling firm
- Mallinckrodt Manufacturing, Madison, WI
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 8 Aug 2023
- FDA classified
- 8 Sep 2023
- Reported
- 20 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 8 Aug 2023 | Recall initiated by company | |
| 8 Sep 2023 | Classified by FDA | +31 days |
| 20 Sep 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
Product as listed by the FDA
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Where it was distributed
Worldwide Distribution
Questions about this recall
Is Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack recalled?
Yes. Mallinckrodt Manufacturing recalled Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack on 8 Aug 2023. The recall is Class I and its status is Ongoing. Recall number Z-2450-2023.
Why was it recalled?
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
Which lots are affected?
a) UDI/DI 10810055283460, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237; b) UDI/DI 10810055283467, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237
Where was it sold?
Worldwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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