VersaCross RF wire lots may have a punctured sterile barrier pouch
The VersaCross RF Wire is being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units are affected.
- Product
- VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.
- Category
- Medical Device
- Distribution
- Distributed nationwide