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.
FDA Recall Z-1148-2021 · Posted None
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Recalling FirmNorthgate Technologies, Inc.
Recall StatusTerminated
Product CodeFCX
Date Initiated2021-01-15
Date Terminated2022-10-31
Product Quantity45 units
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of FL and OH.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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