Z-1147-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 3, 2021
- Initiation Date
- January 15, 2021
- Termination Date
- October 31, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 units
Product Description
ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the abdominal wall for visual examination of the interior or for surgery (laparoscopic surgery).
Reason for Recall
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Distribution Pattern
US Nationwide distribution in the states of FL and OH.
Code Information
Lot Codes: 9855JEG to 93879JEG