FDAFDA · Food and drugs·Recall number Z-0821-2022
Compella Therapy Air Supply Unit
Published March 30, 2022 · Recall initiated: February 14, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- 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.
- Lot
- All lots/serial numbers UDI information: Compella Therapy Air Supply Unit - 00887761013803
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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