Recall Z-0938-2021— Alung Technologies Inc
Class II · Terminated
Class II FDA medical device recall by Alung Technologies Inc, initiated 2020-12-18, terminated 2021-05-17. Product: ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.. Reason: CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolung for EUA, and the infusion pump may have a delivery inaccuracy.
- Recalling firm
- Alung Technologies Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-18
- Terminated
- 2021-05-17
- Firm location
- Pittsburgh, PA, United States
Product description
ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.
Reason for recall
CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolung for EUA, and the infusion pump may have a delivery inaccuracy
Data sourced from openFDA. This site is unofficial and independent of the FDA.