Recall Z-2170-2015— American Medical Systems Innovation Center - Silicon Valley

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 Cleaver; Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP) 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.