Z-1212-2019 Class II Terminated
FDA device recall Z-1212-2019 was initiated by COVIDIEN LLC on March 13, 2019 and is designated Class II. Reason for recall: Sterilization method used was not consistent with the labeling and the approved sterilization method The recall status is terminated (terminated April 23, 2020). Affected quantity: 240 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2019
- Initiation Date
- March 13, 2019
- Termination Date
- April 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 240 units
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
Distribution Pattern
Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
Code Information
Lot Numbers: P8D1335PRX P8D1336PRX P8D1605PRX