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XOMED HYDRODEBRIDER SYSTEM - HANDPIECE (2016-01-20)
- Starting date:
- January 20, 2016
- Posting date:
- February 8, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-57028
Affected Products
XOMED HYDRODEBRIDER SYSTEM - HANDPIECE
Reason
Notification to inform customers of a problem reported with the tubing set that is provided with HydroDebrider Standard Handpiece ref 1914001. Subsequent to complaints from the field, it was discovered that the HydroDebrider tubing assembly (on the spike end) was missing components. This issue does not present a hazard to either patient or user, however, using tubing with the missing components will reduce the overall functionality of the HydroDebrider (reduced force and volume of spray).
Affected products
XOMED HYDRODEBRIDER SYSTEM - HANDPIECE
Lot or serial number
0210082737
Model or catalog number
1914001
Companies
- Manufacturer
-
Medtronic Xomed Inc.
6743 Southpoint Drive North
Jacksonville
Florida
UNITED STATES