BEUDAMED
    FDA Recall Terminated

    FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.

    Recall: Z-1785-2021 · Initiated April 9, 2021

    Recall

    Recall Number
    Z-1785-2021
    Event Number
    87720
    Firm
    Avid Medical, Inc.
    FEI Number
    1047429
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Environmental control
    Initiated
    April 9, 2021
    Posted
    June 4, 2021
    Terminated
    July 18, 2022
    Address
    9000 Westmont Dr, Toano, VA, 23168-9351

    Description

    FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.

    Reason

    Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.

    Action

    A Recall notification letter titled, "URGENT MEDICAL DEVICE CORRECTION" was sent to consignees on 04/09/2021 via a email. End-users were notified on 4/13/21. The letter instructs the consignee to immediately examine all inventory locations and discontinue use of all Halyard or AVID branded Procedure Trays subject to the field action. Discard all affected Procedure Trays found in inventory. In addition, if the consignees has further distributed this product, the notice instructs the consignee to please identify their customers and notify them at once of this product correction and requirements. The notification to the consignee's customers may be enhanced by including a copy of this URGENT MEDICAL DEVICE CORRECTION Notice. The consignee is also asked to please complete the attached Field Action Response Form (page 3) immediately, even if they no longer have any of the recalled lot numbers left in inventory. The completed form is to be emailed to: [email protected]. If the facility has identified affected product in the consignee's inventory, the recall coordinator will reach back to their facility and provide the consignee with paperwork for documenting destruction of the recalled product.

    Distribution

    Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN

    Quantity

    720 kits