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Fujifilm Duodenoscope (2015-12-29)
- Starting date:
- December 29, 2015
- 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-57566
Affected Products
A. Fujifilm Duodenoscope
Reason
The operation manuals containing reprocessing instructions have been updated to reflect newly validated manual cleaning and high-level disinfection procedures. Given publicized reports of multi-drug resistant bacteria on certain duodenoscopes used for endoscopic retrograde cholangiopancreatogram (ERCP) procedures, and in an abundance of caution, Fujifilm has been working with the FDA to validate revised reprocessing procedures that have been provided in the operation manuals. Healthcare providers are being instructed to follow the exact instructions for reprocessing provided in the revised operation manuals in order to minimize the risk of disease transmission.
Affected products
A. Fujifilm Duodenoscope
Lot or serial number
all lots
Model or catalog number
ED-530XT
Companies
- Manufacturer
-
Fujifilm Corporation
26-30 NISHIAZABU, 2 CHOME MINATO-KU
TOKYO-TO
JAPAN