BEUDAMED
    FDA Enforcement Class II Terminated

    Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company

    Recall: Z-2266-2014 · Reported August 27, 2014

    Enforcement

    Recall Number
    Z-2266-2014
    Event ID
    68952
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vascutek, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 27, 2014
    Initiation Date
    July 15, 2014
    Classification Date
    August 18, 2014
    Termination Date
    March 19, 2015
    Address
    Newmains Avenue, Inchinnan, N/A, United Kingdom

    Description

    Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company

    Reason

    The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4 years and 5 years, respectively).

    Code Info

    731030, 731032, 731034, 731036,731038, 731206, 731218, 731220, 731222, 731224, 731226, 731228, 731407, 731506, 731507, 731508, 731509, 731510, 731512, 731514, 731516, 731608, 731809, 732010, 732030, 732032, 732034, 732038, 732211, 732412, 732518, 732520, 732522, 732524, 732526, 732528, 733006, 733007, 733008, 733010, 733012, 733014, 733016, 733018, 733020, 733022, 733024, 733026, 733028, 733030, 733032, 733034, 733036, 733038, 733040, 733042, 734030, 734032, 734034, 734036, 734038, 735018, 735020, 735022, 735024, 735026, 735028, 736006, 736007, 736008, 736010, 736012, 736014, 736016, 736018, 736020, 736022, 736024, 736026, 736028, 736030, 736032, 736034, 736036, 736038, 731206/10/10, 731206/10/10RM, 731206/7, 731407/10/10, 731407/10/10RM, 731407/6X2RM, 731407/7, 731608/10/10, 731608/10/10RM, 731608/6, 731608/7, 731608/7X2RM, 731608/8/10, 731608/8/10RM, 731809/6, 732010/6, 732412/6, 7330303BL, 7330323BL, 7330343BL, 7330363BL, 7330383BL

    Distribution

    Nationwide Distribution including the states of : AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV.

    Quantity

    63,162