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Reusable Active Cord for Bovie Style Electosurgical Generator (2013-11-05)
- Starting date:
- November 5, 2013
- Posting date:
- November 29, 2013
- 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-36915
Recalled Products
Reusable Active Cord for Bovie Style Electosurgical Generator
Reason
To advise users of an updated caution statement in the instructions for use (IFU) which cautions users that the reusable active cords have a restricted service life and should not be used for a period of more than one year. Users are advised that damage or wear to the cord may compromise the integrity of the insulation and this may result in sparking, smoke, the risk of electrical shock or the risk of fire.
Affected products
Reusable Active Cord for Bovie Style Electosurgical Generator
Lot or serial number
Lot: AA through MP, AR, BR
Model or catalog number
RAC-B
Companies
- Manufacturer
-
Gyrus ACMI, Inc.
136 Turnpike Road
Southborough
01772
Massachusetts
UNITED STATES