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Baxter Healthcare Corporation Recall 89644

Description: Compella Therapy Air Supply Unit

Baxter Healthcare Corporation Recall 89644 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0821-2022
Event ID89644
Event DescriptionCompella Therapy Air Supply Unit
Product TypeDevices
DistributionWorldwide 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.
Quantity6022 units
Recall ReasonPotential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
Device Classification20220330
Device Code InfoAll lots/serial numbers UDI information: Compella Therapy Air Supply Unit - 00887761013803
Center Classification Date20220323
Recall Initiation Date20220214
Recalling FirmBaxter Healthcare Corporation
Initial Notification Letter
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