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Hyfrecator 2000
- Starting date:
- February 24, 2017
- Posting date:
- March 16, 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-62652
Reason
A separate accessory package is included in each Hyfrecator 2000 Electrosurgical Unit (ESU) carton. This accessory package contains 2 sterile handpiece sheaths, P/N 7-796-19. From December 2, 2015 to January 3, 2017, the accessory packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 handpiece sheaths in pouches that were labeled as "sterile.”
Affected products
Hyfrecator 2000
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
7-900-115
Companies
- Manufacturer
-
Conmed Corporation
525 French Road
Utica
13502
New York
UNITED STATES