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
Reported: May 1, 2019 Initiated: March 13, 2019 #Z-1211-2019
Product 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
Reason for Recall
Sterilization method used was not consistent with the labeling and the approved sterilization method
Details
- Recalling Firm
- COVIDIEN LLC
- Units Affected
- 7248 units
- Distribution
- Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
- Location
- Mansfield, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by COVIDIEN LLC. Units affected: 7248 units.
Why was this product recalled? ▼
Sterilization method used was not consistent with the labeling and the approved sterilization method
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2019. Severity: Moderate. Recall number: Z-1211-2019.
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