BEUDAMED
    FDA Recall Open, Classified

    Compella Bariatric Bed System

    Recall: Z-0820-2022 · Initiated February 14, 2022

    Recall

    Recall Number
    Z-0820-2022
    Event Number
    89644
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    IOQ
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    February 14, 2022
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Compella Bariatric Bed System

    Reason

    Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

    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.

    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.

    Quantity

    5186 units