COVIDIEN LLC recalls Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument h…

Recall date

March 13, 2019

Source

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

Recall number

Z-1212-2019

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 Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures.