Manufacturer notification to highlight the following changes: 1. Change conditions for ethylene oxide (EtO) gas sterilization from 12% EtO to 100% EtO. 2. Reusable cleaning brush are no longer compatible for the manual cleaning. single use brushes remain compatible and are the recommended choice. Insufficient reprocessing, potentially resulting in contamination with/without subsequent infection, may result when device is utilized in medical procedures where the end user (health care facility) has not implemented these newly revised instructions for use. Recall start date: July 24, 2023
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