Smiths Medical ASD, Inc. has recalled approximately 164,832 Portex Venn Reusable Tracheal Tube Introducers and Portex Tracheal Tube Exchange Guides. The recall was issued because fluid can leak into the device during the cleaning and sterilization process, specifically between the end cap and the tube. This fluid ingress can cause staining or lead to trapped liquids remaining inside the device after cleaning. Additionally, the disinfectants previously recommended in the instruction manual—Hypochlorite Solution and 4% Acetic Acid—have been found inadequate for the disinfection standards required for these specific medical devices.
Fluids trapped inside a medical device that is intended for reuse can lead to bacterial growth or the transfer of biological contaminants between patients. This poses a significant risk of infection or cross-contamination during medical procedures. No incidents or injuries have been reported to date.
Reprocessing Fluid Ingress and Inadequate Disinfection correction
Includes model numbers REF 14-504-17 and REF 14-504-17JP.
Includes model numbers REF 14-504-68 and REF 14-504-68JP.
Includes model number REF 14-504-76.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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