Baxter Healthcare Corporation: Compella Therapy Air Supply Unit

Is my product affected?

Compella Therapy Air Supply Unit

• UPC 00887761013803

Check against the official notice below — it lists the full affected range.

What happened

Baxter Healthcare Corporation has recalled the Compella Therapy Air Supply Unit worldwide due to a potential hazard involving the power cord. The power cord may become damaged in a way that exposes electrical conductors, which could create a risk of electric shock from the power supply. Approximately 6,022 units have been affected across numerous countries including the United States, Canada, Australia, and many others in Europe, the Middle East, Asia, Africa, and the Caribbean.

The recall affects all lots and serial numbers of the Compella Therapy Air Supply Unit (UDI: 00887761013803). However, the recall record does not specify what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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: 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, Turkmenista Quantity: 6022 units Lot/code info: All lots/serial numbers UDI information: Compella Therapy Air Supply Unit - 00887761013803

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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