Reported Jul 29, 2015 · Terminated
Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP) The Fiber Cleaver is a…
American Medical Systems Innovation Center - Silicon Valley
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Medical Systems Innovation Center - Silicon Valley · 3070 Orchard Dr · San Jose, CA · 95134-2011
Is this the product you have?
- 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.
- Lot codes and dates
Model 0010-0760All product manufactured from April 82012 to April 82015
- Amount recalled
- 16,710 total all affected devices
This recall covers 32 products
The agency filed one notice per product. You are reading one of them; the other 31 are below.
19 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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