This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
PENTAX VIDEO DUODENOSCOPE (2016-03-03)
- Starting date:
- March 3, 2016
- Posting date:
- March 17, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-57562
Affected Products
A. PENTAX VIDEO DUODENOSCOPE
Reason
PENTAX Medical has been working with the U.S. Food and Drug Administration ("FDA") as part of an industry-wide initiative to determine what additional steps, if any, could be undertaken to reduce the risk of infection in flexible endoscopes used for ERCP procedures. The updated reprocessing IFUs were developed after rigorous validation testing and ongoing discussions with FDA to further enhance the safety margin and show with a high degree of assurance that the updated reprocessing IFUs, when followed correctly, effectively clean and disinfect the duodenoscope.
Affected products
A. PENTAX VIDEO DUODENOSCOPE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ED-3490TK
Companies
- Manufacturer
-
Hoya Corporation
2-7-5 Naka-ochiai
Shinjuku-ku