BEUDAMED
    FDA Enforcement Class II Terminated

    RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472

    Recall: Z-2202-2018 · Reported June 20, 2018

    Enforcement

    Recall Number
    Z-2202-2018
    Event ID
    80169
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiodynamics Inc. (Navilyst Medical Inc.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2018
    Initiation Date
    May 10, 2018
    Classification Date
    June 14, 2018
    Termination Date
    May 13, 2020
    Address
    10 Glens Falls Tech Park, N/A, Glens Falls, NY, 12801-3864, United States

    Description

    RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472

    Reason

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

    Code Info

    UPN: H96560M0354721; Lot: 5312194

    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

    3 boxes