BEUDAMED
    FDA Enforcement Class II Terminated

    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.

    Recall: Z-1202-2017 · Reported February 22, 2017

    Enforcement

    Recall Number
    Z-1202-2017
    Event ID
    76448
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Vascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 22, 2017
    Initiation Date
    February 10, 2017
    Classification Date
    February 15, 2017
    Termination Date
    December 6, 2017
    Address
    26531 Ynez Rd, N/A, Temecula, CA, 92591-4630, United States

    Description

    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.

    Reason

    Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip.

    Code Info

    Part No. 14679-01 50908K1 50916K1 51013K1 51021K1 51106K1 5101241 5101441 5101941 5102141 5102741 5103141 5110541 5111041 5121041 5121541 5121741 5122341 6012641 6012941 6020341 6020841 6021141 6021641 6021841 6022541 6022941 6030341 6030841 6041241 Part No. 14679-02 50831K1 50903K1 50911K1 50921K1 50924K1 50929K1 51002K1 51008K1 51016K1 51026K1 51029K1 51103K1 5111741 5112041 5112441 5112741 5120141 5120441 6010641 6011141 6011441 6011941 6012241 6031041 6031541 6032241 6032941 6041941 6042141 6042641 6042941 6051141 6051341 6051941 6052441 6061541 6100341

    Distribution

    US: Germany, Italy, Puerto Rico, Spain, Sweden, Switzerland,

    Quantity

    170,008 units total (83,029 units in US)