BEUDAMED
    FDA Enforcement Class II Terminated

    (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269

    Recall: Z-0249-2019 · Reported October 31, 2018

    Enforcement

    Recall Number
    Z-0249-2019
    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

    (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269

    Reason

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

    Code Info

    (1)Lot number: 52418, 51418 Exp. Date: 5/1/2021 (2) Lot Number:51418 Exp Date: 5/1/2021

    Distribution

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

    Quantity

    (1) 180 units (2)180 units