BEUDAMED
    FDA Enforcement Class II Terminated

    8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826

    Recall: Z-0656-2019 · Reported December 26, 2018

    Enforcement

    Recall Number
    Z-0656-2019
    Event ID
    81607
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    COVIDIEN LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 26, 2018
    Initiation Date
    November 5, 2018
    Classification Date
    December 20, 2018
    Termination Date
    August 14, 2020
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113, United States

    Description

    8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826

    Reason

    The product was released into commercial distribution while subject to importation refusal.

    Code Info

    Lot Number 1816211264

    Distribution

    The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.

    Quantity

    32,071 units