American Medical Systems Recalls Fiber Stripper Due to Sterilization Validation Issues
American Medical Systems is recalling Fiber Strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a failure to meet validation guidance for sterilization, which is a regulatory and quality control issue rather than a reported injury or high-risk pathogen, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
American Medical Systems Innovation Center - Silicon Valley is recalling the Fiber Stripper, 910µm, Autoclavable. This tool is 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 affects 16,710 devices manufactured between April 8, 2012, and April 8, 2015.
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 devices were distributed worldwide, including in the United States and numerous other countries.
Users of these devices should stop using the affected Fiber Strippers and contact American Medical Systems for further instructions on the recall.
The recalled product
- Product
- Fiber Stripper, 910¿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
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)
- ModelS0-10008-003
- 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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