BEUDAMED
    FDA Enforcement Class II Terminated

    Cardiac Insulation Pad, OPEN HEART CDS

    Recall: Z-2979-2018 · Reported September 12, 2018

    Enforcement

    Recall Number
    Z-2979-2018
    Event ID
    78411
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 12, 2018
    Initiation Date
    April 12, 2017
    Classification Date
    September 6, 2018
    Termination Date
    August 5, 2019
    Address
    1170 S Northpoint Blvd, N/A, Waukegan, IL, 60085-6757, United States

    Description

    Cardiac Insulation Pad, OPEN HEART CDS

    Reason

    Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation pad, Medline component number 32369. The non-sterile component (32369) was placed within the non-sterile portion of the CDS assembly. This component should have been placed inside the sterile portion of the pack where it would have subsequently been exposed to an ethylene oxide sterilization process. This component was not placed in the sterile portion of the pack and was not sterilized, resulting in the inadvertent release of this item in a non-sterile state. The contents of the sterile kit were properly sterilized and the remaining contents of the non-sterile subassembly had the appropriate sterility status based on their intended use.

    Code Info

    Model: CDS984745C; Lots: 17GD0936, 17FD1655, 17ED3419, 17ED1482, 17ED0636, 17DD0666, 17DD0296, 17AD1912, 16LD3005, 16LD0059, 16JD3201, 16ID3179, 16HD1298, 16GD0779, 16FD3925, 16CD0303 and 16AD4032

    Distribution

    CA, NM

    Quantity

    77 kits