Home / Recalls / American Medical Systems Innovation Center - Silicon Valley / Z-2174-2015

Z-2174-2015 Class II Terminated

Recalled by American Medical Systems Innovation Center - Silicon Valley — San Jose, CA

FDA device recall Z-2174-2015 was initiated by American Medical Systems Innovation Center - Silicon Valley on May 28, 2015 and is designated Class II. Reason for recall: 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 … The recall status is terminated (terminated January 19, 2016). Affected quantity: 16,710 total affected devices.

Recall Details

Product Type: Devices
Report Date: July 29, 2015
Initiation Date: May 28, 2015
Termination Date: January 19, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 16,710 total affected devices

Product Description

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, corresponding to the Endostat or SureFlex Fiber core diameter size.

Reason for Recall

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

Distribution Pattern

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.

Code Information

Model 80-10002-001; All product manufactured from April 8, 2012 to April 8, 2015

Other recalls by American Medical Systems Innovation Center - Silicon Valley

Z-2167-2015 Class II — Fiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided fo (May 28, 2015)
Z-2177-2015 Class II — Tool, Stripper W/BLD, 14S, Autoclavable; The Fiber Stripper is a tool provide (May 28, 2015)
Z-2182-2015 Class II — Tool, Stripper W/BLD, 28S, Nonautoclavable; The Fiber Stripper is a tool prov (May 28, 2015)
Z-2161-2015 Class II — Sureflex 910 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended (May 28, 2015)
Z-2179-2015 Class II — Tool, Stripper W/BLD, 18S, Autoclavable; The Fiber Stripper is a tool provide (May 28, 2015)
Z-2186-2015 Class II — Stripper, 0.3mm Disposable EndoStat Fiber, The Fiber Stripper is a tool prov (May 28, 2015)
Z-2172-2015 Class II — Tool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool prov (May 28, 2015)
Z-2187-2015 Class II — Stripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool prov (May 28, 2015)
Z-2173-2015 Class II — Tool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool provide (May 28, 2015)
Z-2180-2015 Class II — Tool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool prov (May 28, 2015)