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.
FDA Recall Z-1018-2015 · Posted 2015-02-03
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Recalling FirmCovidien
Recall StatusTerminated
Product CodeKRA
Date Initiated2014-12-10
Date Terminated2016-03-31
Product Quantity1032 devices (919 US, 113 OUS)
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.
Firm Action
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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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