Home / Recalls / Mallinckrodt Manufacturing LLC / Z-2450-2023

Z-2450-2023 Class I Ongoing

Recalled by Mallinckrodt Manufacturing LLC — Madison, WI

Recall Details

Product Type: Devices
Report Date: September 20, 2023
Initiation Date: August 8, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 13,602 units

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.

Distribution Pattern

Worldwide Distribution

Code Information

a) UDI/DI 10810055283460, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237; b) UDI/DI 10810055283467, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237