COVIDIEN LLC recalls Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has…

Recall date

March 13, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1211-2019

FDA classification

Class II

Brand / firm

COVIDIEN LLC

Sold / distributed

Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.

Why it was recalled

Sterilization method used was not consistent with the labeling and the approved sterilization method

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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