Recall Z-0579-2015— ArthroCare Medical Corporation
Class II · Terminated
Class II FDA medical device recall by ArthroCare Medical Corporation, initiated 2014-10-27, terminated 2015-10-09. It names one FDA 510(k) clearance: K083306. 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.. Reason: Potential breach of sterile barrier due to defective product tray..
- Recalling firm
- ArthroCare Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-27
- Terminated
- 2015-10-09
- Firm location
- Austin, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Potential breach of sterile barrier due to defective product tray.
Data sourced from openFDA. This site is unofficial and independent of the FDA.