Z-1148-2021Class II

Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 -

Name: Z-1148-2021 Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 -
Creator: Northgate Technologies, Inc.
Published: 2021-01-15
License: https://open.fda.gov/license/

Northgate Technologies Inc. / initiated 2021-01-15 / Terminated / root cause: manufacturing process

FDA source

Northgate Technologies, Inc. began a recall of Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the... on 2021-01-15. FDA classified it as Class II and gives the reason as "An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1148-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-15
Posted: 2021-02-24
Terminated: 2022-10-31
Recalling firm: Northgate Technologies Inc.
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.
Product code: FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot Codes: 93830JEK to 93854JEK; 93899LEK to 93908LEK; 93909LEK to 93918LEK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1148-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1147-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-24
Z-1148-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-24

Product code FCX

K111648Class IIBracco Diagnostics, Inc. Co2mpact Endodcopic InsufflatorBracco Diagnostic, Inc. / cleared 2011-11-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)