Z-0821-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 30, 2022
- Initiation Date
- February 14, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6022 units
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.
Distribution Pattern
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.
Code Information
All lots/serial numbers UDI information: Compella Therapy Air Supply Unit - 00887761013803