BEUDAMED
    FDA Recall Terminated

    Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886

    Recall: Z-2193-2018 · Initiated May 10, 2018

    Recall

    Recall Number
    Z-2193-2018
    Event Number
    80169
    Firm
    Angiodynamics Inc. (Navilyst Medical Inc.)
    FEI Number
    3017892510
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    May 10, 2018
    Terminated
    May 13, 2020
    Address
    10 Glens Falls, Tech Park Glens Falls, NY, 12801-3864

    Description

    Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886

    Reason

    A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

    Action

    Urgent Medical Device Recall letters were sent to customers on 5/10/18. The letters instructed customers to do the following: IMMEDIATELY Stop using the product subject to recall. Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). Segregate this product in a secure location for return to AngioDynamics, Inc. Forward a copy of this recall notification to all sites to which you have distributed affected product. Complete and return the Reply Verification Tracking Form. If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.

    Distribution

    The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

    Quantity

    58 boxes