Baxter Healthcare Corporation Compella Therapy Air Supply Unit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Compella Therapy Air Supply Unit
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
All lots/serial numbers UDI information: Compella Therapy Air Supply Unit - 00887761013803
Products Sold
All lots/serial numbers UDI information: Compella Therapy Air Supply Unit - 00887761013803
Baxter Healthcare Corporation is recalling Compella Therapy Air Supply Unit due to Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
Recommended Action
Per FDA guidance
Customer notification letters were mailed beginning 02/21/2022. A localized customer letter will be mailed (with signature service) to all first-level consignees by Sedgwick. The letter will inform the customer of the issue, reason for Field Action and provide risk mitigations. The customer will be instructed to sign acknowledgement form to confirm receipt and return to a dedicated email address. Distributors will be asked to forward to their end users. Distributors will be provided with instructions on communication with their end users. All consignees will be required to return a signed acknowledgment form and confirm that they read and understand the issue. Distributors will be asked to forward to their end users. Distributors will be provided instruction on communication with their end users.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026