FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant regulatory non-compliance regarding sterilization validation for reusable medical devices.
Plain-English summary
American Medical Systems Innovation Center - Silicon Valley is recalling 16,710 units of the Tool, Stripper W/BLD, 12S, Nonautoclavable (Model 80-10002-001). These tools are used to strip the protective jacket off the end of Endostat or SureFlex Fibers and do not come into direct contact with patients. The affected units were 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. This is classified as an FDA Class II recall.
The devices were distributed worldwide, including in the United States and numerous other countries such as Argentina, France, Germany, and the United Kingdom. Users should stop using the affected tools and contact the manufacturer for further instructions.
The recalled product
- Product
- Tool, Stripper W/BLD, 12S, Nonautoclavable; 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, corresp
- 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 80-10002-001
- 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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