BEUDAMED
    FDA Enforcement Class II Terminated

    CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL

    Recall: Z-0265-2019 · Reported October 31, 2018

    Enforcement

    Recall Number
    Z-0265-2019
    Event ID
    81179
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Custom Healthcare Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 31, 2018
    Initiation Date
    August 13, 2018
    Classification Date
    October 25, 2018
    Termination Date
    August 1, 2022
    Address
    4205 Eubank Rd, N/A, Richmond, VA, 23231-4328, United States

    Description

    CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL

    Reason

    Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

    Code Info

    Lot Number: :W72118 Exp Date:7/1/2021

    Distribution

    Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,

    Quantity

    89 units