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U.S. Department of Health and Human Services

Class 2 Device Recall Fiber Stripper

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  Class 2 Device Recall Fiber Stripper see related information
Date Initiated by Firm May 28, 2015
Date Posted July 21, 2015
Recall Status1 Terminated 3 on January 19, 2016
Recall Number Z-2165-2015
Recall Event ID 71534
Product Classification Powered laser surgical instrument - Product Code GEX
Product Fiber Stripper, 200¿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 to the Endostat or SureFlex Fiber core diameter size.
Code Information Model 80-10001-003; All product manufactured from April 8, 2012 to April 8, 2015
Recalling Firm/
Manufacturer		 American Medical Systems Innovation Center - Silicon Valley
3070 Orchard Dr
San Jose CA 95134-2011
For Additional Information Contact Jennifer Mascioli-Tudor
408-456-3320 Ext. 6703
Manufacturer Reason
for Recall		 validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sure flex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products
FDA Determined
Cause 2		 Reprocessing Controls
Action Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
Quantity in Commerce 16, 710 total affected devices
Distribution Worldwide Distribution - US Nationwide in the countries of: Argentina France Morocco, South Africa, Australia, Germany, Netherlands, Spain, Austria, Greece, New Zealand, Sri Lanka, Belgium, Guatemala, Norway, Switzerland, Bolivia, India, Panama, Thailand, Brazil, Ireland, Peru, Turkey, Canada, Israel, Poland, United Kingdom, Chile, Italy, Portugal, United States, Colombia, Korea, Qatar, Uruguay, Costa Rica, Lebanon, Romania, Finland, Malaysia and Saudi Arabia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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