Recall Z-2171-2015— 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: 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 Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient.. 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
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 Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient.
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.