Compella Bariatric Bed System
FDA Recall Z-0820-2022 · Posted None
Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeIOQ
Date Initiated2022-02-14
Date Terminated2026-07-02
Product Quantity5186 units
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.
Firm Action
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.
Root Cause
Labeling design
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.