Recall Z-1147-2021
Northgate Technologies, Inc. · initiated January 15, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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).
Codes / lots: Lot Codes: 9855JEG to 93879JEG
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.
FDA-determined 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.
Details
- Recall number
- Z-1147-2021
- Initiated
- January 15, 2021
- Terminated
- October 31, 2022
- Product code
- HIF – Insufflator, Laparoscopic
- Quantity
- 25 units
- Distribution
- US Nationwide distribution in the states of FL and OH.
- Recalling firm
- Northgate Technologies, Inc., Elgin, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1148-2021 Class II | Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 -…An internal tubing component in the flow path was made with incorrect material which was not tested for use… | 01/15/2021Terminated |