BEUDAMED
    FDA Enforcement Class II Terminated

    Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy

    Recall: Z-0637-2018 · Reported February 28, 2018

    Enforcement

    Recall Number
    Z-0637-2018
    Event ID
    79052
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 28, 2018
    Initiation Date
    January 22, 2018
    Classification Date
    February 16, 2018
    Termination Date
    August 19, 2020
    Address
    200 Debusk Ln, N/A, Powell, TN, 37849-4703, United States

    Description

    Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy

    Reason

    DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve.

    Code Info

    Lot numbers: 43097391, 43685581, 44750305, 45377442, 45464669, 45698684, 46203903

    Distribution

    US Distribution to: NY

    Quantity

    181 units