FDA Recalls Fiber Cleavers Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Cleavers because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.
- Product
- 1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser…
- Category
- Medical Device
- Distribution
- Distributed nationwide