The Recall Desk

FDA (Devices) recall action 70048

Covidien recalled 2 products on 2015-02-11

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-02-11
Critical
0
Units
—

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • ModerateFDA (Devices)··2015-02-11

    FDA Recalls Covidien Trellis-8 Peripheral Infusion Systems Due to Labeling Error

    FDA is recalling 1,032 units of the Covidien Trellis-8 Peripheral Infusion System because a manufacturing error caused the proximal and distal balloon inflation ports to be incorrectly labeled.

    Product
    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 in
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-02-11

    FDA Recalls Covidien Trellis-6 Peripheral Infusion Systems Due to Labeling Error

    The FDA is recalling 216 units of the Covidien Trellis-6 Peripheral Infusion System because a manufacturing error caused the balloon inflation ports to be incorrectly labeled.

    Product
    Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature
    Category
    Distribution
    0 states