Recall Z-1446-2020 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Covidien Llc
Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934
| Date | Feb 25, 2020 (initiated Feb 10, 2020) |
| Status | Terminated |
| Reason | Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection. |
| Root cause | Process control |
| Action | On February 10, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed of the packaging issue and instructed to do the following: 1. Please immediately quarantine and discontinue use of the affected item codes and lots listed in the notice. 2. Please return affected product as indicated in the notice. All unused products from the affected item codes and lots must be returned. 3. If you have distributed Covidien Force TriVerse electrosurgical devices listed on Attachment A, please promptly forward the information from this letter to those |
| Quantity | 70361 |
| Distribution | Nationwide domestic distribution. Foreign distribution to Australia, Canada, Austria Belgium Canary Islands Czech Republic Denmark Finland France Germany Greece Hungary Italy Jordan Kazakhstan Kenya Lithuania Luxembourg North Macedonia Poland Portugal Reunion Romania Russian Federation Serbia Slovak |
| 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 |