Recall of Covidien Force TriVerse Electrosurgical Devices Due to Packaging Risk
The FDA is recalling 70,361 units of Covidien Force TriVerse Electrosurgical Devices because sterile packaging may be compromised, increasing the risk of infection.
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 is classified as FDA Class II. The hazard involves a risk of infection due to compromised sterile packaging, which fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported.' No specific injuries or illnesses are reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 70,361 units of Covidien Force TriVerse Electrosurgical Devices, product numbers FT3000 and FT3000DB. The recall was initiated by the manufacturer, Covidien LLC, due to a potential defect in the sterile packaging.
The source text states that the sterile packaging may potentially be compromised. Use of these products may result in an increased risk for infection. The affected devices were distributed domestically across the United States and internationally to numerous countries in Europe, the Middle East, and Africa, including Australia, Canada, and the United Kingdom.
Healthcare facilities and users should stop using the affected devices immediately. The source text does not specify a particular consumer action beyond the general implication of halting use to prevent infection. Users should contact the manufacturer or their supplier for further instructions on replacement or return.
The recalled product
- Product
- Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934
- Manufacturer
- Covidien Llc
- Affected units
- 70,361
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Covidien Llc 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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