BEUDAMED
    FDA Enforcement Class II Terminated

    Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

    Recall: Z-2099-2014 · Reported July 30, 2014

    Enforcement

    Recall Number
    Z-2099-2014
    Event ID
    68404
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2014
    Initiation Date
    May 23, 2014
    Classification Date
    July 22, 2014
    Termination Date
    February 24, 2015
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586, United States

    Description

    Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

    Reason

    During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

    Code Info

    Part No. 4948, Lot #: 0646471, 0652314, 0652909, 0656645, 0658692, 0662071, 0666665, 0669799, 0672089, 0675750, 0676585, 0678728, 0681792, 0684780, 0685667, 0688001, 0691202, 0693823, 0694711, 0696205, 0698300, 0708186, 0708766, 0710058, 0711914, 0714958, 0716134, 0717932, 0719278, 0721688, 694711R, 696201R; Part No. 4949, Lot #: 0646532, 0650731, 0651656, 0652458, 0655167, 0659823, 0661134, 0666626, 0667247, 0668568, 0669798, 0672411, 0675022, 0677305, 0677868, 0678727, 0681772, 0683304, 0683963, 0685668, 0687773, 0688994, 0694411, 0694706, 0695244, 0698301, 0703802, 0708185, 0708765, 0710054, 0711276, 0715262, 0716637, 0718634, 0720571, 695244R, 696204R; Part No. 4949X, Lot #: 0645381, 0653211, 0661604, 0667107, 0669928, 0684001, 0694715, 0712872, 694715R; Part No. 4950, Lot #: 0648462, 0650495, 0656442, 0657280, 0660743, 0674021, 0678721, 0681807, 0684779, 0687498, 0689723, 0693829, 0698851, 0708778, 0710056, 0711836, 0713283, 0719706, 693829R, 695465R; Part No. 4951, Lot #: 0645876, 0649394, 0653430, 0660668, 0661526, 0667894, 0668979, 0674463, 0675778, 0677306, 0678217, 0681808, 0686128, 0687960, 0694412, 0696144, 0696612, 0698299, 0702118, 0708768, 0710037, 0711275, 0713301, 0722066, 696144R & Part No. 4951X, Lot #: 0668569, 0677303, 0696145, 0712873, 696145R.

    Distribution

    Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, 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, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.

    Quantity

    135,340 units