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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0027-2027

Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 18) RED Model/Catalog Number: A70107006 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

Publicado el 7 de octubre de 2026 · Inicio del retiro: 24 de agosto de 2026

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
ASP Global, LLC.
Distribuidor
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.
Lote
Lot Code: Model Number: A70107006 UDI-DI: (01) 00885914035504 All Lots produced from 01SEP2016 to 01MAR2023: S0823STY, S0922STY, S1214STY, R0601STY, R1101STY, Q0930STY, Q1115STY, P0325STY, P1015STY, O0815STY, N0330STY, N0730STY, M0130STY, M0730STY, M0930STY
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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Preguntas sobre este retiro

¿Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 18) RED Model/Catalog Number: A70107006 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 fue retirado del mercado?

Sí. FDA publicó el retiro Z-0027-2027 el 7 de octubre de 2026. Peligro reportado: 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.

¿Qué debo hacer si tengo este producto?

Voluntary: Firm initiated · Letter

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