Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0773-06

LigaSure Atlas 20 cm Open Procedure Vessel Sealer/Divider

Medtronic, Inc. / initiated 2006-01-27 / Terminated

Covidien LP began a recall of LigaSure Atlas 20 cm Open Procedure Vessel Sealer/Divider on . The reason FDA records is "Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0773-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medtronic, Inc.
Product
LigaSure Atlas 20 cm Open Procedure Vessel Sealer/Divider
Product code
GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall
Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal.
FDA root cause
Other
Action
Consignees were notified by letter on 01/27/2006.
Quantity in commerce
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.
Product codes and lots
Catalog Number LS1120. Lot numbers: Any lot number beginning with N2, N3, N4, or N5A through N5L235K.