FDA recall Z-2450-2023

Mallinckrodt Manufacturing LLC · Class I · device

Product

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

Worldwide Distribution

Key facts

Status
Ongoing
Initiation date
2023-08-08
Report date
2023-09-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Madison, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2450-2023