Recall Z-0821-2022— Baxter Healthcare Corporation
Class II · Ongoing
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2022-02-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Compella Therapy Air Supply Unit. Reason: Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-02-14
- Firm location
- Deerfield, IL, United States
Product description
Compella Therapy Air Supply Unit
Reason for recall
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
Data sourced from openFDA. This site is unofficial and independent of the FDA.