XOMED HYDRODEBRIDER SYSTEM - HANDPIECE (2016-01-20) — recall 54868
Health Canada — Medical Devices · Canada · 2016-02-08 · Type III
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Reported risk: 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).
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