Galway, Ireland
Medtronic formerly Covidien recalls
1 recall recorded since 2018, most recently on 25 March 2022. 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
- 25 March 2022
- Reason
- The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.
- Distribution
- US Nationwide - Worldwide .Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0966-2022
- Puritan Bennett 980 Series Ventilator
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.