Device 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
Z-1211-2019
Product summary
- Firm
- COVIDIEN LLC
- Event
- Event 82426
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7248 units
- Official record key
device-enforcement:Z-1211-2019
Official wording
Reason: Sterilization method used was not consistent with the labeling and the approved sterilization method
Code information: Lot Numbers: P8D1333PRX P8D1334PRX P8D1614PRX P8D1615PRX P8D1616PRX P8E1143PRX P8E1189PRX P8E1269PRX P8E1271PRX P8E1272PRX P8F0008PRX P8F1238PRX P8F1239PRX P8F1307PRX P8F1448PRX P8F1452PRX P8F1480PRX P8F1545PRX
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