Omni-Tract Surgical Retractor System

Product Omni-Tract Surgical Retractor System Issue Medical devices - Sterility What to do Contact the manufacturer if you require additional information. Audience Healthcare Industry

Integra Lifesciences is issuing a correction to the Integra® Omni-Tract® Surgical Retractor System - existing Instructions For Use (IFU) related to prevacuum sterilization dry time requirements, to ensure the Omni-Tract® devices and components are properly dried during sterilization to qualify current ISO standards. The current Omni-Tract® Surgical Retractor System IFU states a dry time of 30 minutes. The validated drying times utilizing standard pre-vacuum temperature and time standards were significantly longer and needed to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.

RA-82277