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).
Reported: March 3, 2021 Initiated: January 15, 2021 #Z-1147-2021
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.
Details
- Recalling Firm
- Northgate Technologies, Inc.
- Units Affected
- 25 units
- Distribution
- US Nationwide distribution in the states of FL and OH.
- Location
- Elgin, IL
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Northgate Technologies, Inc.. Units affected: 25 units.
Why was this product recalled? ▼
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 3, 2021. Severity: Moderate. Recall number: Z-1147-2021.
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