BEUDAMED
    FDA Recall Terminated

    1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit

    Recall: Z-2329-2017 · Initiated May 9, 2017

    Recall

    Recall Number
    Z-2329-2017
    Event Number
    77232
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    May 9, 2017
    Terminated
    September 17, 2018
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit

    Reason

    Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

    Action

    Arrow International sent an Urgent Medical Device Recall Notification Letter dated May 11, 2017, to affected customers. The firm's notification letter is requesting that customers immediately assess their current inventory and to discontinue and quarantine any product with the specific lot codes listed in the letter. In addition, customers were asked to complete the Recall Acknowledgement form and fax or email it back to Customer Service so they can receive a Returns Good Authorization Number for the product's return. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.

    Distribution

    Worldwide Distribution - US (nationwide) and Canada

    Quantity

    27,485 units distributed in U.S, 4,371 units distributed internationally