Holmium Laser Fiber, Flexor Vue Deflecting Endoscopic System, and Vueoptic Visulation Source (2017-04-24)

Starting date:

April 24, 2017

Posting date:

June 7, 2017

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-63516

• 
  Reason
• 
  Affected products

Affected Products

A. Holmium Laser Fiber, Multi Use

B. Flexor Vue Deflecting Endoscopic System

C. Vueoptic Visualization Source

Reason

The reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products. Our preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet current standards. There have been no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilization associated with these devices.

Affected products