Madison, WI, United States
Mallinckrodt Manufacturing LLC recalls
1 recall recorded since 2018, most recently on 8 August 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 8 August 2023
- Reason
- The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2450-2023
- Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.