Z-0636-2018 Class II Terminated
FDA device recall Z-0636-2018 was initiated by Covidien LLC on September 13, 2017 and is designated Class II. Reason for recall: Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time. The recall status is terminated (terminated June 28, 2019). Affected quantity: 3,816.
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2018
- Initiation Date
- September 13, 2017
- Termination Date
- June 28, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,816
Product Description
Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Reason for Recall
Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.
Distribution Pattern
Nationally
Code Information
N7F1058KX, N7F1121KX, N7F1056KX, N7F1057KX