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Health product recall

Gas/Water Feeding Valves (2014-07-14)

Starting date:
July 14, 2014
Posting date:
September 24, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-41485

Recalled products

  1. Gas/Water Feeding  Valves 

Reason

During a colonoscopy, patient experienced a perforation of the colon. Surgery was performed. After the colonoscopy the devices were flushed as per normal routine. During the after-use process it was observed that the CO2 flow through the colono scope couldn't be stopped by the CO2 valve of-B194. Patient subsequently passed away.

Affected products

A. Gas/Water Feeding  Valves

Lot or serial number

All lots

Model or catalog number
  • OF-B130
  • OF-B194
Companies
Manufacturer
Hoya Corporation
2-7-5 Naka-Ochiai, Shinjuku-ku,
Tokyo, Tokyo-to
161-8525
JAPAN