Reported Jul 29, 2015 · Terminated
Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off…
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?
- Tool, Stripper W/BLD, 44S, 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.
- Lot codes and dates
Model 80-10008-002All product manufactured from April 82012 to April 82015
- Amount recalled
- 16,710 total 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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