ArthroCare Medical Recalls Ambient HipVac and KVac Wands for Sterile Barrier Breach
ArthroCare Medical Corporation is recalling 23,119 Ambient HipVac and KVac wands due to a potential breach of the sterile barrier caused by defective product trays.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where a sterile barrier breach could lead to infection, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
ArthroCare Medical Corporation is recalling 23,119 units of the Ambient HipVac 50 Wand (Model ASHA4730-01) and the Ambient KVac Wand (Model ASHA5050-01). These medical devices are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
The recall is being conducted because of a potential breach of the sterile barrier due to a defective product tray. This defect could compromise the sterility of the devices, posing a risk of infection if used in surgical procedures.
The affected devices were distributed nationwide in the United States and in the following countries: Austria, Australia, Belgium, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Ireland, Malaysia, Netherlands, Norway, Poland, Spain, South Africa, Sweden, Switzerland, Turkey, and the UK. Specific lot numbers for both models are listed in the official recall documentation. Healthcare providers and facilities should stop using the affected devices and contact ArthroCare Medical Corporation for instructions on return or replacement.
The recalled product
- 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 vessel
- Manufacturer
- ArthroCare Medical Corporation
- Affected units
- 23,119
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number ASHA4730-01 (HipVac) lot numbers: 1021255
- 1021620
- 1022188
- 1022482
- 1022636
- 1023089
- 1024067
- 1025482
- 1025480
- 102481
- 1025764
- 1025765
- 1026875
- 1027163
- 1027702
- 1028327
- 1029265
- 1030025
- 1031353
- 1031759
Distribution
Distributed nationwide across the United States.
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