Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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-

U.S. FDA — Device Enforcement · United States · 2014-12-10 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1018-2015
Date of alert: 2014-12-10
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Covidien
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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