FDA Recalls Sureflex 365 Lithotripsy Fibers Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Sureflex 365 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
- Product
- Sureflex 365 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
- Category
- Medical Device
- Distribution
- Distributed nationwide