American Medical Systems Innovation Center - Silic Recall: Tool, Stripper W/BLD, 18S, Nona
American Medical Systems Innovation Center - Silic Recall: Tool, Stripper W/BLD, 18S, Nona is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: American Medical Systems Innovation Center - Silicon Valley; Product: Tool, Stripper W/BLD, 18S, Nonautoclavable; The Fiber Stripper is a tool prov
| Recalling firm | American Medical Systems Innovation Center - Silicon Valley |
|---|---|
| Product | Tool, Stripper W/BLD, 18S, 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 |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| 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, Israe |
| Recall initiated | 20150528 |
| Recall number | Z-2178-2015 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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