Health product recall

CO2MPACT Endoscopic Insufflator (2021-03-04)

Starting date:
March 4, 2021
Posting date:
April 1, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-75275

Last updated: 2021-04-01

Affected Products 

CO2MPACT Endoscopic Insufflator

Reason

Recall was initiated because an internal tubing component in the flow part used the incorrect tubing. The component is made of nylon tubing instead of polyethylene material. The nylon tubing has not been tested for use in this device, and has been shown to exhibit increased kinking which could lead to restricted flow from the unit.

Affected products

CO2MPACT Endoscopic Insufflator

Lot or serial number
  • 93833JEK
  • 93847JEK
  • 93854JEK
Model or catalog number
  • 710300
Companies
Manufacturer
United States Endoscopy Group Inc. trading as US Endoscopy
5976 HEISLEY ROAD,
MENTOR
44060
Ohio
UNITED STATES