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U.S. Department of Health and Human Services

Class 2 Device Recall Steris CO2MPACT Endoscopic Insufflator

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  Class 2 Device Recall Steris CO2MPACT Endoscopic Insufflator see related information
Date Initiated by Firm January 15, 2021
Create Date February 24, 2021
Recall Status1 Terminated 3 on October 31, 2022
Recall Number Z-1148-2021
Recall Event ID 87231
510(K)Number K111648  
Product Classification Insufflator, automatic carbon-dioxide for endoscope - Product Code FCX
Product 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.
Code Information Lot Codes: 93830JEK to 93854JEK; 93899LEK to 93908LEK; 93909LEK to 93918LEK
Recalling Firm/
Manufacturer		 Northgate Technologies, Inc.
1591 Scottsdale Ct
Elgin IL 60123-9361
For Additional Information Contact Laura MacMillian
800-348-0424
Manufacturer 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 2		 Nonconforming Material/Component
Action 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.
Quantity in Commerce 45 units
Distribution US Nationwide distribution in the states of FL and OH.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FCX and Original Applicant = BRACCO DIAGNOSTIC, INC.
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