BEUDAMED
    FDA Enforcement Class II Terminated

    Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350

    Recall: Z-1358-2020 · Reported March 4, 2020

    Enforcement

    Recall Number
    Z-1358-2020
    Event ID
    84908
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    March 4, 2020
    Initiation Date
    January 21, 2020
    Classification Date
    February 25, 2020
    Termination Date
    January 12, 2023
    Address
    Three Lakes Drive, N/A, Northfield, IL, 60093, United States

    Description

    Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350

    Reason

    The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.

    Code Info

    REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350

    Distribution

    California only. No governmental, Canadian or Mexican consignees. TORRANCE MEMORIAL MEDICAL 3105 LOMITA BLVD TORRANCE CA 905055108 HOAG MEMORIAL HOSPITAL 1 HOAG DR NEWPORT BEACH CA 926634162 OWENS/MINORVMI TEM (65) 5125 ONTARIO MILLS PKWY ONTARIO CA 917645103

    Quantity

    122