medical Class II Updated 2021-03-03

Northgate Technologies, Inc. recalls Steris CO2MPACT Endoscopic Insufflator system, Catalog Numbe

Recalled 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.


Hazard / Issue

An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Codes: 93830JEK to 93854JEK; 93899LEK to 93908LEK; 93909LEK to 93918LEK
View official government recall

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