PlainRecalls
FDA Devices Moderate Class II Ongoing

Compella Therapy Air Supply Unit

Reported: March 30, 2022 Initiated: February 14, 2022 #Z-0821-2022

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.

Details

Units Affected
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.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Compella Therapy Air Supply Unit. Recalled by Baxter Healthcare Corporation. Units affected: 6022 units.
Why was this product recalled?
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 30, 2022. Severity: Moderate. Recall number: Z-0821-2022.