Recall of Force TriVerse Electrosurgical Kits Due to Sterility Concerns
Covidien is recalling Force TriVerse Electrosurgical Kits distributed in EMEA due to potential sterile packaging compromise, which may increase infection risk.
What this means for you
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 risk-of-harm product (infection risk) where injury has not yet been reported, fitting the 'High' severity criteria for medical devices with potential but unconfirmed harm.
Plain-English summary
Covidien LLC is recalling kits containing Force TriVerse Electrosurgical Devices. These kits are manufactured in The Netherlands and were distributed exclusively in the EMEA region (Europe, Middle East, and Africa). There is no U.S. distribution of these kits.
The recall was initiated because the sterile packaging may potentially be compromised. The use of these products may result in an increased risk for infection. Specific lot numbers are listed in the official recall documentation.
Healthcare providers and facilities in the EMEA region should stop using these kits and contact the manufacturer for further instructions. Consumers in the United States are not affected by this recall.
The recalled product
- Product
- Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distribution. Kits are manufactured in The Netherlands. Item codes BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREA
- Manufacturer
- Covidien Llc
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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