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
Enforcement
- Recall Number
- Z-1211-2019
- Event ID
- 82426
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- COVIDIEN LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 1, 2019
- Initiation Date
- March 13, 2019
- Classification Date
- April 23, 2019
- Termination Date
- April 23, 2020
- Address
- 15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States
Description
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
Sterilization method used was not consistent with the labeling and the approved sterilization method
Lot Numbers: P8D1333PRX P8D1334PRX P8D1614PRX P8D1615PRX P8D1616PRX P8E1143PRX P8E1189PRX P8E1269PRX P8E1271PRX P8E1272PRX P8F0008PRX P8F1238PRX P8F1239PRX P8F1307PRX P8F1448PRX P8F1452PRX P8F1480PRX P8F1545PRX
Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
7248 units