Class IIDeviceOngoing

ASP Global, LLC.

Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-Line, Plum Model/Catalog Number: ASP-564003 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.

Details

Recall number: Z-0038-2027
Event ID: 99676
Recall initiated: Aug 24, 2026
Classified: Oct 1, 2026
Reported: Oct 7, 2026
Quantity: 10060
Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Austell, GA, United States
Lot / code info: Lot Code: Model Number: ASP-564003 UDI-DI: (01) 00840216106703 All Lots produced from 01SEP2016 to 01MAR2023: P1015STY, P1215STY, N0330STY, N0530STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY