Recall Z-2168-2015— American Medical Systems Innovation Center - Silicon Valley
Class II · Terminated
Class II FDA medical device recall by American Medical Systems Innovation Center - Silicon Valley, initiated 2015-05-28, terminated 2016-01-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Fiber Stripper, 550¿m, Autoclavable; 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, corresponding to the Endostat or SureFlex Fiber core diameter size.. Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products.
- Recalling firm
- American Medical Systems Innovation Center - Silicon Valley
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-28
- Terminated
- 2016-01-19
- Firm location
- San Jose, CA, United States
Product description
Fiber Stripper, 550¿m, Autoclavable; 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, corresponding to the Endostat or SureFlex Fiber core diameter size.
Reason for recall
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products
Data sourced from openFDA. This site is unofficial and independent of the FDA.