American Medical Systems Recalls Fiber Stripper Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential failure to meet sterilization validation guidance for a reusable medical device, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
American Medical Systems Innovation Center - Silicon Valley is recalling 16,710 units of the Fiber Stripper, 365µm, Autoclavable (Model 80-10005-003). The recall affects all product manufactured between April 8, 2012, and April 8, 2015. The device is a tool used to strip the protective jacket off the end of an Endostat or SureFlex Fiber and does not come into direct contact with the patient.
The recall was initiated because validation data related to cleaning instructions and sterilization methods for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new FDA guidance on qualifying reusable products. The agency has classified this as a Class II recall.
The affected devices were distributed worldwide, including in the United States and numerous other countries such as Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Spain, Switzerland, and the United Kingdom. Users should stop using the affected Fiber Strippers and contact American Medical Systems for further instructions.
The recalled product
- Product
- Fiber Stripper, 365¿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
- Affected units
- 16,710
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model 80-10005-003
- All product manufactured from April 8
- 2012 to April 8
- 2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 recalled by American Medical Systems Innovation Center - Silicon Valley under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 32 products in this recall →Related recalls
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