Device product
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.
Z-1212-2019
Product summary
- Firm
- COVIDIEN LLC
- Event
- Event 82426
- Status
- Terminated
- Classification
- Class II
- Quantity
- 240 units
- Official record key
device-enforcement:Z-1212-2019
Official wording
Reason: Sterilization method used was not consistent with the labeling and the approved sterilization method
Code information: Lot Numbers: P8D1335PRX P8D1336PRX P8D1605PRX
Distribution pattern: Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
Derived failure modes
-
Unknown
Sterilization method used was not consistent with the labeling and the approved sterilization method