Recall Z-1020-2019 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Covidien, PLC
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
| Date | Feb 15, 2019 |
| Status | Terminated |
| Reason | Potential for the sterile packaging to be compromised |
| Root cause | Equipment maintenance |
| Action | Medtronic notified via letter by Federal Express and/or certified mail on February 15, 2019. The letter informs customers of the recall of one production lot of Covidien Force TriVerse" electrosurgical devices 10 cord due to the potential for the sterile packaging to be compromised and the actions they should take. Through this notification customers are instructed to take the following actions: " Immediately quarantine and discontinue use of the affected item code and lot. " Return affected product. " Forward the information to anyone who they have distributed affected Covidien Force TriVers |
| Quantity | 850 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150735 | Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot Covidien, Aug 4, 2015 |