BEUDAMED
    FDA Enforcement Class I Terminated

    Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    Recall: Z-1018-2015 · Reported February 11, 2015

    Enforcement

    Recall Number
    Z-1018-2015
    Event ID
    70048
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 11, 2015
    Initiation Date
    December 10, 2014
    Classification Date
    February 2, 2015
    Termination Date
    March 31, 2016
    Address
    4600 Nathan Ln N, N/A, Plymouth, MN, 55442-2890, United States

    Description

    Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    Reason

    A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. Units have been identified to have the distal balloon inflation port incorrectly labeled as proximal, and, the proximal balloon port incorrectly labeled as distal.

    Code Info

    Model CVT808015, Lot numbers: 9895996, 9904675, 9910270, 9911926, 9912084, 9912200, 9922490, 9922584, 9922597, 9922601, 9922604, 9922606, 9922617, 9922620, 9922624, 9922635, 9923420, 9924840, 9928078, 9932274, 9933341, 9933774, 9933839, 9933934, 9934029, 9934440, 9934633, 9934686, 9936420, 9937544, 9937660, 9942679, 9943032, 9945436, 9948145, 9949409, 9950000, 9950703. Model CVT808025, Lot numbers: 9904237, 9906429, 9910270, 9912003, 9912117, 9912261, 9922644, 9922658, 9922661, 9922663, 9922739, 9922862, 9922868, 9923391, 9923401, 9923405, 9923428, 9923437, 9923454, 9924796, 9924802, 9924826, 9924847, 9924853, 9928334, 9928629, 9929004, 9929248, 9929344, 9933577, 9933797, 9933903, 9934553, 9934772, 9935134, 9935174, 9935241, 9935245, 9935471, 9935523, 9935757, 9935889, 9936140, 9936631, 9936680, 9936702, 9936735, 9937706, 9938500, 9938960, 9939918, 9939985, 9940234, 9940687, 9940916, 9948001, 9948544, 9949603, 9950150, 9950722, 9951391, 9952404, 9952785, 9952844, 9959913. Model CVT812015, Lot Numbers: 9904401, 9904676, 9910934, 9912387, 9922742, 9922793, 9922886, 9922892, 9922902, 9922904, 9922917, 9923224, 9923226, 9923237, 9923268, 9923275, 9923398, 9923446, 9923453, 9924832, 9932594, 9933474, 9933813, 9933924, 9934192, 9934730, 9936820, 9937095, 9937806, 9942701, 9943235, 9945140. Model CVT812025, Lot Numbers: 9910342, 9911492, 9911683, 9911812, 9912503, 9922498, 9922750, 9922753, 9922873, 9922911, 9923246, 9923403, 9923404, 9923409, 9923426, 9923442, 9923450, 9923457, 9924848, 9925351, 9933666, 9934311, 9934575, 9934700, 9935143, 9935199, 9935494, 9935636, 9935900, 9936109, 9936173, 9936570, 9936597, 9936848, 9937896, 9937968, 9938060, 9938219, 9938831, 9938896, 9941711, 9945304, 9947559, 9948088, 9949321, 9949934, 9950324, 9951247, 9951521, 9952927, 9957277, 9957530, 9959854, 9959944, 9960241, 9960324, 9960635, 9960807, 9961583, 9961682, 9962504, 9963558, 9964120, 9964347, 9964448, 9965066, 9965335, 9966329, 9966429, 9966999, 9967656, 9967694, 9968180, 9969396, 9972428, 9972429, 9972819, 9972867, 9972966.

    Distribution

    Worldwide Distribution - US Nationwide and the countries Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

    Quantity

    1032 devices (919 US, 113 OUS)