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COVIDIEN LLC recalls Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm
Recalled May 1, 2019 · FDA recall Z-1211-2019 · COVIDIEN
Hazard
Sterilization method used was not consistent with the labeling and the approved sterilization method · FDA Class II
Units
7248 units
Sold at
Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
Description
Sterilization method used was not consistent with the labeling and the approved sterilization method
Product
Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with the use of a converter. The atraumatic jaws are clamped and locked onto tissue structures by closing the handles
Manufacturer(s)
COVIDIEN LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →