Z-2450-2023Class I

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

Name: Z-2450-2023 Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with...
Creator: Mallinckrodt Manufacturing LLC
Published: 2023-08-08
License: https://open.fda.gov/license/

Mallinckrodt Manufacturing LLC / initiated 2023-08-08 / Open, Classified

FDA source

Mallinckrodt Manufacturing LLC began a recall of Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators on 2023-08-08. FDA classified it as Class I and gives the reason as "The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2450-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-08-08
Posted: 2023-09-09
Recalling firm: Mallinckrodt Manufacturing LLC
Product: Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Product code: BZO Set, Tubing And Support, Ventilator (W Harness)
Reason for recall: The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
FDA root cause: Under Investigation by firm
Action: Mallinckrodt Pharmaceuticals issued an URGENT: MEDICAL DEVICE RECALL NOTICE to its consignees on 08/08/2023 via FedEx. the notice explained the issue, risks associated with the failure, and requested the return of the device.
Quantity in commerce: 13,602 units
Distribution: Worldwide Distribution
Product codes and lots: a) UDI/DI 10810055283460, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237; b) UDI/DI 10810055283467, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2450-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2450-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-08

Product code BZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)