FDA-Device2014-12-17Class II
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.
ArthroCare Medical Corporation
Hazard
Potential breach of sterile barrier due to defective product tray.
Sold states
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.
Affected count
23,119 devices
Manufactured in
7000 W William Cannon Dr, N/A, Austin, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0579-2015Don't want to check this manually?
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