Clarksville, TN, United States
The Biomed Guys recalls
1 recall recorded since 2018, most recently on 25 March 2021. 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 2021
- Reason
- Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.
- Distribution
- Us distribution to the states of IN and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1651-2021
- Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
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.