BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0680-2018 · Initiated July 24, 2017

    Recall

    Recall Number
    Z-0680-2018
    Event Number
    78951
    Firm
    Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
    FEI Number
    1000120555
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 24, 2017
    Terminated
    November 7, 2019
    Address
    87 Venture Dr, Dover, NH, 03820-5914

    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.

    Action

    Vygon sent recall letters dated July 24, 2017, to customers via email and fax with read receipts and delivery confirmations. The recall letter informed customers of the reason for recall, product description, code and lot number, and instructions to customers, with a Recall Acknowledgement and Inventory Return Form provided/accompanying the recall letter.

    Distribution

    U.S.

    Quantity

    300 units