FDA Recalls 850 Units of Covidien Force TriVerse Electrosurgical Devices
The FDA is recalling 850 units of the Covidien Force TriVerse electrosurgical device due to potential sterile packaging compromise.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential sterile packaging compromise, which poses a risk of infection or harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 850 units of the Covidien Force TriVerse electrosurgical device, item code FT3000F. The recall is being conducted by the manufacturer, Covidien, PLC, for devices distributed nationwide in the United States.
The recall is issued because of a potential for the sterile packaging to be compromised. This single-use device is intended to provide electrosurgical energy to cut and/or coagulate tissue during open and minimally invasive arthroscopic procedures. The affected lot number is 80390309X.
Healthcare facilities and consumers should stop using the affected devices and contact the manufacturer or the FDA for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and…
- Manufacturer
- Covidien, PLC
- Affected units
- 850
Distribution
Distributed nationwide across the United States.
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