BEUDAMED
    FDA Recall Terminated

    Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam

    Recall: Z-0586-2020 · Initiated October 22, 2019

    Recall

    Recall Number
    Z-0586-2020
    Event Number
    84229
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    FLE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 22, 2019
    Terminated
    June 9, 2020
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam

    Reason

    The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and loading car unexpectedly falling forward

    Action

    Steris Corp. issued URGENT DEVICE FIELD CORRECTION dated 10/22/19 informing users reason for recall, and action to take: A STERIS Service Technician will contact your facility to repair your unit(s). Users can continue to use the transfer carriage prior to this repai r. Users are advised to use caution when operating the transfer carriage, and avoid bumping into other equipment or rolling over uneven surfaces. If you have questions regarding this matter, please contact STERIS Technical Support, at 800-333-8828, STERIS Customer Service at 1-800-548-4873, or your local STERIS Representative.

    Distribution

    Nationwide Foreign: Canada, Peru, Mexico, Brazil, Saudi Arabia, Columbia

    Quantity

    237 units