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Recall Observatory FDA recall evidence

Device product

Compella Therapy Air Supply Unit

Z-0821-2022

February 14, 2022

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 89644
Status
Terminated
Classification
Class II
Quantity
6022 units
Official record key
device-enforcement:Z-0821-2022

Official wording

Reason: Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

Code information: All lots/serial numbers UDI information: Compella Therapy Air Supply Unit - 00887761013803

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.