ASP Global, LLC. — Class II: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 12
ASP Global, LLC. has initiated a Class II recall for Expressaire disposable tourniquet cuffs due to an incorrect expiration date on labeling. Products manufactured between September 2016 and March 2023 were labeled with a 10-year shelf life, while the validated shelf life is only 5 years.
This recall affects healthcare facilities using Expressaire disposable tourniquet cuffs (Model A70107001) and regulatory/QA professionals responsible for sterile device shelf-life validation and labeling accuracy.
The discrepancy between labeled and validated shelf life suggests a potential breakdown in the transition from stability testing results to labeling specifications. For sterile, non-invasive devices like tourniquet cuffs, exceeding the validated shelf life could potentially compromise material integrity or packaging sterility, though the source does not explicitly state the specific failure mode. This underscores the regulatory necessity of ensuring that all marketing and labeling claims are strictly supported by primary validation data.
Review inventory for Expressaire cuffs (Model A70107001) manufactured between 2016 and 2023. Update internal product master data to reflect the validated 5-year shelf life. Verify that existing CAPA processes address the discrepancy between validated stability data and label claims.
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, 8" X 2.5" 2-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107001 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