Medtronic Recalls Trellis 6 and 8 Peripheral Infusion Systems for Sterility Breach
Medtronic is voluntarily recalling Trellis 6 and 8 Peripheral Infusion Systems due to potential sterility breaches in the outer packaging.
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: This is a voluntary precautionary recall for a potential packaging defect where the source explicitly states the internal device sterility is not directly affected, fitting the criteria for moderate severity.
Plain-English summary
Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems. The recall is due to the potential for a sterility breach of the outer packaging or pouch material.
A breach of the outer pouch may compromise the outside surface sterility of the inner pouch. However, the source text states that this does not directly affect the sterility of the device components within the inner pouch.
The affected products are intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The recall covers 8,269 units distributed in the United States and various countries worldwide.
The recalled product
- Product
- Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EU
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
Distribution
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