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EVOTECH Endoscope Cleaner & Reprocessor (2015-05-14)
- Starting date:
- May 14, 2015
- Posting date:
- June 10, 2015
- 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-53737
Recalled Products
A. EVOTECH Endoscope Cleaner & Reprocessor
Reason
Advanced Sterilization Products recently determined that the Evotech endoscope cleaner and reprocessor (ECR) may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope. This is not a removal of the Evotech ECR and customers may continue to use the device in accordance with the user's guide until a system correction is available.
Affected products
A. EVOTECH Endoscope Cleaner & Reprocessor
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
50014-101
50014-102
Companies
- Manufacturer
-
Advanced Sterilization Products
A Division of Ethicon
33 Technology Drive
Irvine
92618
UNITED STATES