BEUDAMED
    FDA Enforcement Class II Terminated

    CVC Tray Pediatrics. Product Code: AMS-9335CP-2.

    Recall: Z-0680-2018 · Reported February 28, 2018

    Enforcement

    Recall Number
    Z-0680-2018
    Event ID
    78951
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 28, 2018
    Initiation Date
    July 24, 2017
    Classification Date
    February 21, 2018
    Termination Date
    November 7, 2019
    Address
    87 Venture Dr, N/A, Dover, NH, 03820-5914, United States

    Description

    CVC Tray Pediatrics. Product Code: AMS-9335CP-2.

    Reason

    Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.

    Code Info

    Lot Number: 1706044D

    Distribution

    U.S.

    Quantity

    300 units