FDA Device recall Z-2173-2015
Tool, StripperW/BLD, 10S, Autoclavable
- FDA Device
- Class II
- terminated
- Published 2015-07-29
On 2015-07-29 the FDA classified a Class II recall of Tool, StripperW/BLD, 10S, Autoclavable by American Medical Systems Innovation Center Silicon Valley, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2173-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-28 |
| Published | 2015-07-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | American Medical Systems Innovation Center Silicon Valley |
| Distribution | US |
Product
Tool, StripperW/BLD, 10S, 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.
Reason
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
Identifiers
| code_info | Model 80-10001-002; All product manufactured from April 8, 2012 to April 8, 2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2173-2015%22
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