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.
FDA Recall Z-0579-2015 · Posted 2014-12-16
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Recalling FirmArthroCare Medical Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2014-10-27
Date Terminated2015-10-09
Product Quantity23,119 devices
Reason for Recall
Potential breach of sterile barrier due to defective product tray.
Firm Action
The firm notified their consignees on 10/29/14 via letter with a response form included. The letter requested the consignees discontinue use of the device and return it to the vendor.
Root Cause
Package design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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