ClearanceBrief
Recall Z-0772-06 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories

Covidien LP

LigaSure Atlas Laparoscopic Vessel Sealer/Divider

DateApr 19, 2006 (initiated Jan 27, 2006)
StatusTerminated
ReasonSealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal.
Root causeOther
ActionConsignees were notified by letter on 01/27/2006.
Quantity124,000 units domestic, 126,000 units internationally.
DistributionNationwide, 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 recordOpen on fda.gov

510(k) clearances named in this recall

K010013LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100
Valleylab, Inc., Mar 26, 2001