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.
This recall has been terminated (originally issued February 3, 2015).
- Company
- Covidien
- Recall Initiated
- December 10, 2014
- Posted
- February 3, 2015
- Terminated
- March 31, 2016
- Recall Number
- Z-1018-2015
- Quantity
- 1032 devices (919 US, 113 OUS)
- Firm Location
- Plymouth, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution - US Nationwide and the countries Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Lot / 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.
Root Cause
Mixed-up of materials/components
Action Taken
Consignees were sent an Urgent Product Recall letter dated 12/15/2014. The letter described the issue, identified the affected product, and the required actions. Affected product was to be returned directly to customers' Covidien Sales Rep; or customers were to contact Covidien Service at 1-800-716-6700 to arrange for product return. Questions can be directed to the Covidien Sales Rep or to Covidien Service at 1-800-716-6700. Customers were to complete and return the Verification Form along with the unused product as soon as possible.