BEUDAMED
    FDA Recall Terminated

    CHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538

    Recall: Z-0258-2019 · Initiated August 13, 2018

    Recall

    Recall Number
    Z-0258-2019
    Event Number
    81179
    Firm
    Custom Healthcare Systems, Inc.
    FEI Number
    1121091
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    August 13, 2018
    Terminated
    August 1, 2022
    Address
    4205 Eubank Rd, Richmond, VA, 23231-4328

    Description

    CHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538

    Reason

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

    Action

    Custom Healthcare Systems (CHS) initiated recall by phone, email and by certified mail on 8/13/18 and carried out to the end user. Custom Healthcare Systems Inc. notified the customers, they were informed to contact their account to receive the product. Product to be returned and credited.

    Distribution

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

    Quantity

    150 units