FDAFDA · Food and drugs·Recall number Z-1212-2019
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.
Published May 1, 2019 · Recall initiated: March 13, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterilization method used was not consistent with the labeling and the approved sterilization method
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- COVIDIEN LLC
- Distributor
- Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
- Lot
- Lot Numbers: P8D1335PRX P8D1336PRX P8D1605PRX
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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