BEUDAMED
    FDA Enforcement Class II Terminated

    Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300

    Recall: Z-2388-2021 · Reported September 8, 2021

    Enforcement

    Recall Number
    Z-2388-2021
    Event ID
    88476
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aspen Surgical Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 8, 2021
    Initiation Date
    July 23, 2021
    Classification Date
    August 30, 2021
    Termination Date
    July 26, 2022
    Address
    6945 Southbelt Dr SE, N/A, Caledonia, MI, 49316-7664, United States

    Description

    Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300

    Reason

    Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.

    Code Info

    All lots manufactured between July 9, 2019 to July 9, 2021

    Distribution

    US nationwide distribution. No foreign distribution.

    Quantity

    1429