Device recall
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-Line, White Model/Catalog Number: ASP-564011 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
- Recall number
- Z-0044-2027
- Event id
- 99676
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- ASP Global, LLC.
- Report date
- Oct 7, 2026
- Posted
- Oct 1, 2026
- Initiated
- Aug 24, 2026
- Center classification date
- Oct 1, 2026
- Product code
- KCY
- Device type
- Tourniquet, Pneumatic
- 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.
- Root cause
- Under Investigation by firm
- Quantity
- 45960
- Code info
- Lot Code: Model Number: ASP-564011 UDI-DI: (01) 00840216106765 All Lots produced from 01SEP2016 to 01MAR2023: P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0430STY, M0730STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Austell, GA, United States