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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a reasonable probability of serious adverse health consequences. However, the specific defect is a labeling error on a medical device, and the source text does not report any illnesses, injuries, or deaths. Under the rubric, a labeling error without reported harm is classified as Moderate.
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 in
- 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.
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