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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1018-2015

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.

Publicado el 11 de febrero de 2015 · Inicio del retiro: 10 de diciembre de 2014

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Covidien
Distribuidor
Worldwide Distribution - US Nationwide and the countries Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Lote
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.
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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