Recall Z-0019-2027— ASP Global, LLC.
Class II · Ongoing
Class II FDA medical device recall by ASP Global, LLC., initiated 2026-08-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 26" X 6" 1-LINE (CS 10) ORANGE Model/Catalog Number: 564019 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. 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..
- Recalling firm
- ASP Global, LLC.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-24
- Firm location
- Austell, GA, United States
Product description
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 26" X 6" 1-LINE (CS 10) ORANGE Model/Catalog Number: 564019 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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.