Omni-Tract Surgical Retractor System

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.Update: Integra LifeSciences is issuing this additional updated correction to the Integra® Omni-Tract® Surgical Retractor System - Instructions for Use (IFU) adding prevacuum sterilization parameters when using a rigid container.  Previously, in our June 2026 communication, Integra LifeSciences provided drying times solely for polypropylene wrapped sterilization trays informing you of three (3) the dry times (90 minutes, 110 minutes, or 120 minutes) depending on the sterilization cycle exposure time. This updated notification contains additional sterilization testing validated using a rigid container with the updated prevacuum sterilization cycle parameters.

Status

Active

Key date

Aug 11, 2026

Provinces

National

Added

Aug 12, 2026