The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1018-2015·Announced 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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 1,032 units of the Covidien Trellis-8 Peripheral Infusion System. The affected models are CVT808015, CVT808025, CVT812015, and CVT812025. The recall covers units distributed in the United States and internationally, including Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.

The recall was initiated due to a manufacturing error that resulted in the incorrect identification of the proximal and distal balloon inflation ports. Specifically, the distal balloon inflation port was incorrectly labeled as proximal, and the proximal balloon port was incorrectly labeled as distal. This labeling error could lead to the incorrect inflation of the balloon during use.

Healthcare facilities and distributors should identify the affected units by checking the model numbers and lot numbers listed in the official recall notice. Users should stop using the affected devices and contact the manufacturer or the FDA for further instructions on how to return or dispose of the units.

The recalled product

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…
Manufacturer
Covidien
Category
Medical Device — Infusion System
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model CVT808015
  • Lot numbers: 9895996
  • 9904675
  • 9910270
  • 9911926
  • 9912084
  • 9912200
  • 9922490
  • 9922584
  • 9922597
  • 9922601
  • 9922604
  • 9922606
  • 9922617
  • 9922620
  • 9922624
  • 9922635
  • 9923420
  • 9924840
  • 9928078

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Covidien under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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