Largo, FL, United States
Infinium Medical, Inc recalls
1 recall recorded since 2018, most recently on 31 May 2019. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 31 May 2019
- Reason
- The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.
- Distribution
- Distributed nationwide to California, Georgia, Louisiana, Florida, Maryland, Minnesota, Puerto Rico, South Carolina, Virginia, Wisconsin.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1926-2019
- CLEO Patient Monitor /Tranquility VS Patient Monitor
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.