ASP Global, LLC.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
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
Lot Code: Model Number: 553323 UDI-DI: (01) 00885914010549 All Lots produced from 01SEP2016 to 01MAR2023: Q1115STY
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →