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Coolief Sinergy Cooled Radiofrequency Kit (2016-06-17)
- Starting date:
- June 17, 2016
- Posting date:
- July 7, 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, Healthcare Professionals, Hospitals
- Identification number:
- RA-59244
Affected products
A. Coolief Sinergy Cooled Radiofrequency Kit
Reason
A mismatch was identified between the length of the RF electrode (probe) and the cannula (introducer). There were 75 mm long introducers packaged with 100 mm probes, which if present and used, could potentially lead to an injury.
Affected products
A. Coolief Sinergy Cooled Radiofrequency Kit
Lot or serial number
M5264D205
Model or catalog number
SIK-17-75-4
Companies
- Manufacturer
-
HALYARD HEALTH, INC.
5405 WINDWARD PARKWAY
ALPHARETTA
30004
Georgia
UNITED STATES