Recall Z-0773-06 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Covidien LP
LigaSure Atlas 20 cm Open Procedure Vessel Sealer/Divider
| Date | Apr 19, 2006 (initiated Jan 27, 2006) |
| Status | Terminated |
| Reason | Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal. |
| Root cause | Other |
| Action | Consignees were notified by letter on 01/27/2006. |
| Quantity | 123,000 units domestic, 126,000 units internationally. |
| Distribution | Nationwide, including 52 VA facilities and 12 military facilities. Foreign distribution to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Curacao, Germany, Guatamala, Israel, Japan, Mexico, Paraguay, Peru, Singapore, South Africa, Uruguay, Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010013 | LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 Valleylab, Inc., Mar 26, 2001 |