Northgate Recalls Steris CO2MPACT Endoscopic Insufflator Systems Due to Tubing Material Error
Northgate Technologies is recalling 45 Steris CO2MPACT Endoscopic Insufflator systems because an internal tubing component was made with incorrect, untested material.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a material defect that was not tested for use, representing a risk-of-harm product where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Northgate Technologies, Inc. is recalling 45 units of the Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300. The device is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
The recall was initiated because an internal tubing component in the flow path was made with incorrect material that was not tested for use with this device. The affected units were distributed nationwide in the United States, specifically in the states of Florida and Ohio. The lot codes for the recalled units range from 93830JEK to 93854JEK, 93899LEK to 93908LEK, and 93909LEK to 93918LEK.
Healthcare facilities and users should stop using the affected devices immediately and contact Northgate Technologies for further instructions on the recall process.
The recalled product
- 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.
- Manufacturer
- Northgate Technologies, Inc.
- Hazard
- Affected units
- 45
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Codes: 93830JEK to 93854JEK
- 93899LEK to 93908LEK
- 93909LEK to 93918LEK
Distribution
Part of a larger recall action
This product is one of 2 recalled by Northgate Technologies, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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