Compella Bariatric Bed System
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- February 14, 2022
- Recall Number
- Z-0820-2022
- Quantity
- 5186 units
- Firm Location
- Deerfield, IL
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, Turkmenistan, UAE, and UK.
Lot / Code Info
All lots/serial numbers UDI information: Compella Bariatric Bed - 00887761000902
Root 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.