Recall Z-0821-2022
Baxter Healthcare Corporation · initiated February 14, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Compella Therapy Air Supply Unit
Codes / lots: All lots/serial numbers UDI information: Compella Therapy Air Supply Unit - 00887761013803
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.
FDA-determined cause: Labeling design
Action taken
Customer notification letters were mailed beginning 02/21/2022. A localized customer letter will be mailed (with signature service) to all first-level consignees by Sedgwick. The letter will inform the customer of the issue, reason for Field Action and provide risk mitigations. The customer will be instructed to sign acknowledgement form to confirm receipt and return to a dedicated email address. Distributors will be asked to forward to their end users. Distributors will be provided with instructions on communication with their end users. All consignees will be required to return a signed acknowledgment form and confirm that they read and understand the issue. Distributors will be asked to forward to their end users. Distributors will be provided instruction on communication with their end users.
Details
- Recall number
- Z-0821-2022
- Initiated
- February 14, 2022
- Terminated
- July 2, 2026
- Product code
- IOQ – Bed, Flotation Therapy, Powered
- Quantity
- 6022 units
- 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…
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0820-2022 Class II | Compella Bariatric Bed SystemPotential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of… | 02/14/2022Terminated |