FDA-Device2019-05-01Class II
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.
COVIDIEN LLC
Hazard
Sterilization method used was not consistent with the labeling and the approved sterilization method
Sold states
Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
Affected count
240 units
Manufactured in
15 Hampshire St, N/A, Mansfield, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1212-2019Don't want to check this manually?
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