Recall Z-1020-2019— Covidien, PLC
Class II · Terminated
Class II FDA medical device recall by Covidien, PLC, initiated 2019-02-15, terminated 2020-06-17. It names one FDA 510(k) clearance: K150735. 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 minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F. Reason: Potential for the sterile packaging to be compromised.
- Recalling firm
- Covidien, PLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-02-15
- Terminated
- 2020-06-17
- Firm location
- Boulder, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F
Reason for recall
Potential for the sterile packaging to be compromised
Data sourced from openFDA. This site is unofficial and independent of the FDA.