FDA Recalls American Medical Systems Fiber Strippers for Validation Issues
American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet new FDA guidance for reusable products.
- Product
- Stripper, 0.3mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresp
- Category
- Medical Device
- Distribution
- Distributed nationwide