ASP Global, LLC. — Class II: Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER,
ASP Global, LLC. initiated a Class II recall for Expressaire disposable dual bladder tourniquet cuffs due to incorrect labeling regarding product expiration. The devices were labeled with a 10-year shelf life, while the validated shelf life is only five years.
This recall affects ASP Global, LLC., surgical facilities using Expressaire tourniquet cuffs (Model A70107017), and personnel responsible for sterile inventory management and surgical preparation.
The discrepancy between labeled and validated shelf life presents a potential risk regarding the integrity of the device or its sterile barrier over time. This suggests a failure in the transition between validation data and labeling controls. Regulatory teams should consider the implications for long-term inventory manufactured between 2016 and 2023, as products may technically be expired according to validated data despite their labeled dates.
QA and supply chain teams should immediately identify and quarantine affected inventory based on the listed model number. Regulatory teams must update labeling and shelf-life documentation to reflect the validated five-year limit and initiate a reconciliation process for products manufactured since 2016.
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 BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 2-LINE (CS 12) ORANGE Model/Catalog Number: A70107017 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.
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