Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
- Company
- Northgate Technologies, Inc.
- Recall Initiated
- January 15, 2021
- Terminated
- October 31, 2022
- Recall Number
- Z-1148-2021
- Quantity
- 45 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: 93830JEK to 93854JEK; 93899LEK to 93908LEK; 93909LEK to 93918LEK
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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