ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 10) RED Model/Catalog Number: 564006 Software Versi
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- ASP Global, LLC.
- Product
- Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 10) RED Model/Catalog Number: 564006 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 / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-08-24
- Code info
- Lot Code: Model Number: 564006 UDI-DI: (01) 00885914044568 All Lots produced from 01SEP2016 to 01MAR2023: S0922STY, S1101STY, S1214STY, R0310STY, R0601STY, R0801STY, R1101STY, R1201STY, Q0930STY, Q1115STY, P1015STY, O0120STY, N0330STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, M1230STY
- Product quantity
- 25350
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Austell
- State
- GA
- Country
- United States
- Event id
- 99676
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