BEUDAMED
    FDA Enforcement Class II Terminated

    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

    Recall: Z-0463-2020 · Reported November 27, 2019

    Enforcement

    Recall Number
    Z-0463-2020
    Event ID
    84125
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2019
    Initiation Date
    October 21, 2019
    Classification Date
    November 18, 2019
    Termination Date
    June 30, 2020
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    Description

    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

    Reason

    The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

    Code Info

    REF (RPN): HNB5.0-38-80-P-NS-HS2 REF (GPN): G10598 Lot Numbers: NS9904742, NS9906243, NS9906244, NS9914968, NS9914970, NS9928941, NS9943480, NS9943481 UDIs: (01)00827002105980(17)220731(10)NS9904742, (01)00827002105980(17)220731(10)NS9906243, (01)00827002105980(17)220801(10)NS9906244, (01)00827002105980(17)220805(10)NS9914968, (01)00827002105980(17)220805(10)NS9914970, (01)00827002105980(17)220809(10)NS9928941, (01)00827002105980(17)220826(10)NS9943480, (01)00827002105980(17)220822(10)NS9943481

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

    Quantity

    45