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