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).
- Company
- Northgate Technologies, Inc.
- Recall Initiated
- January 15, 2021
- Terminated
- October 31, 2022
- Recall Number
- Z-1147-2021
- Quantity
- 25 units
- Firm Location
- Elgin, IL
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
US Nationwide distribution in the states of FL and OH.
Lot / Code Info
Lot Codes: 9855JEG to 93879JEG
Root Cause
Nonconforming Material/Component
Action Taken
The firm initiated the recall on 01/15/2021 by email to its direct consignees. The notice requested the consignee cease distribution or use and return the product to NTI. It also directed the consignee to notify their customers if the product was further distributed.
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