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HydroFinity Hydrophilic Guidwire(2014-06-03)
- Starting date:
- June 3, 2014
- Posting date:
- July 3, 2014
- 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-40235
Recalled Products
HydroFinity Hydrophilic Guidwire
Reason
Reports of the outer polymer jacket to the core wire being damaged during use.
Affected products
HydroFinity Hydrophilic Guidwire
Lot or serial number
All lots contact manufacturer
Model or catalog number
HPRA35150
HPRA35180
HPRA35260
HPRS35150
HPRS35180
HPRS35260
HPSA35150
HPSA35180
HPSA35260
HPSS35150
HPSS35180
HPSS35260
Companies
- Manufacturer
-
Nitinol Devices and Components, Inc.
47533 Westinghouse Drive
Fremont
94539
California
UNITED STATES