Z-0821-2022Class II

Compella Therapy Air Supply Unit

Name: Z-0821-2022 Compella Therapy Air Supply Unit
Creator: Baxter Healthcare Corporation
Published: 2022-02-14
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-02-14 / Terminated / root cause: labeling and UDI

FDA source

Baxter Healthcare Corporation began a recall of Compella Therapy Air Supply Unit on 2022-02-14. FDA classified it as Class II and gives the reason as "Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0821-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-14
Posted: 2022-03-23
Terminated: 2026-07-02
Recalling firm: Baxter Healthcare Corporation
Product: Compella Therapy Air Supply Unit
Product code: IOQ Bed, Flotation Therapy, Powered
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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.
Quantity in commerce: 6022 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Cameroon, Canada, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Jamaica, Jordan, Kuwait, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkmenistan, UAE, and UK.
Product codes and lots: All lots/serial numbers UDI information: Compella Therapy Air Supply Unit - 00887761013803

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0821-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0820-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-30	2022-03-23
Z-0821-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-30	2022-03-23

Product code IOQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)