Recall Z-0579-2015 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ArthroCare Medical Corporation
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.
| Date | Dec 16, 2014 (initiated Oct 27, 2014) |
| Status | Terminated |
| Reason | Potential breach of sterile barrier due to defective product tray. |
| Root cause | Package design/selection |
| 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. |
| Quantity | 23,119 devices |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083306 | MODIFICATION TO ARTHROCARE ARTHROWANDS Arthrocare Corp., Dec 10, 2008 |