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ArthroCare Medical Corporation recalls Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient K
Recalled December 17, 2014 · FDA recall Z-0579-2015 · ArthroCare Medical
Hazard
Potential breach of sterile barrier due to defective product tray. · FDA Class II
Units
23,119 devices
Sold at
Worldwide Distribution-US (nationwide) and the countries of Austria, Australia, Belgium, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Ireland, Malaysia, Netherlands, Norway, Poland, Spain, South Africa, Sweden, Switzerland, Turkey, and UK.
Description
Potential breach of sterile barrier due to defective product tray.
Product
Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Manufacturer(s)
ArthroCare Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →