BEUDAMED
    FDA Recall Terminated

    Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry

    Recall: Z-1779-2019 · Initiated April 18, 2019

    Recall

    Recall Number
    Z-1779-2019
    Event Number
    82650
    Firm
    Skytron, Div. The KMW Group, Inc
    FEI Number
    1825014
    Product Code
    FLE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 18, 2019
    Terminated
    April 17, 2020
    Address
    5085 Corporate Exchange Blvd SE, Grand Rapids, MI, 49512-5515

    Description

    Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry

    Reason

    Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure

    Action

    Skytron issued Medical Device Correction letter on 4/18/19 via certified mail stating: reason for recall, action to be taken and will replace the air heater assembly on the affected devices. Contact Larry Perez, Vice President of Technical Services, at 616-656-2900 or [email protected], or Bob Vreeland, at 616-656-1189 or [email protected] with any questions. For after-hours support, please call 1-800-759-8766 (SKYTRON).

    Distribution

    US Nationwide Distribution - AK, IA, MS

    Quantity

    5 units