ASP Global, LLC. — Class II: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18)
ASP Global, LLC. initiated a Class II recall for Expressaire Disposable Tourniquet Cuffs due to an incorrect 10-year expiration date labeled on products manufactured between September 2016 and March 2023. The actual validated shelf life for these sterile devices is five years.
This affects ASP Global, LLC., healthcare facilities utilizing Expressaire disposable tourniquet cuffs (Model/Catalog Number 553323), and surgical departments responsible for inventory management of sterile non-invasive devices.
The discrepancy between the labeled shelf life and validated data suggests a potential breakdown in design transfer or labeling controls. For sterile surgical devices, using products beyond their validated shelf life may compromise sterility or material integrity, potentially impacting patient safety during procedures requiring blood flow occlusion. The multi-year span of affected production suggests a long-standing oversight in the quality management system regarding stability data application.
Quality teams should audit current inventory for the specified model number and verify if expiration dating aligns with the 5-year validated limit. Regulatory departments may need to update labeling documentation and ensure future manufacturing lots reflect the corrected shelf life to prevent further non-compliance.
Class II. Reason: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.. Product: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18) WHITE Model/Catalog Number: 553323 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No. Firm: ASP Global, LLC. (Austell GA United States). Status: Ongoing.
Open in openFDA / FDA.gov