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.
Reported: May 1, 2019 Initiated: March 13, 2019 #Z-1212-2019
Product Description
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.
Reason for Recall
Sterilization method used was not consistent with the labeling and the approved sterilization method
Details
- Recalling Firm
- COVIDIEN LLC
- Units Affected
- 240 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 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.. Recalled by COVIDIEN LLC. Units affected: 240 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-1212-2019.
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