Tool, Stripper W/BLD, 28S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off t

FDA device recall Z-2183-2015 · posted 2015-07-21 · Terminated

Recall details

Recalling firm

American Medical Systems Innovation Center - Silicon Valley

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

Action taken

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.

Root cause

Reprocessing Controls

Status

Terminated

Product code

GEX

Quantity affected

16,710 total affected d evices

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,

Date initiated

2015-05-28

Date posted

2015-07-21

Date terminated

2016-01-19

Location

San Jose, CA