FDAFDA · Alimentos y medicamentos·N.º oficial Z-2873-2026
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.
Publicado el 19 de agosto de 2026 · Inicio del retiro: 6 de julio 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
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.
Qué hacer
Voluntary: Firm initiated
Detalles del retiro
- Fabricante
- Spectra Medical Devices, Llc
- Distribuidor
- Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
- Lote
- Lot Code: Product codes: 1510-1 (individual ampule) / 1510-2 (carton) Lots: AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005 AB4006, AB5001, AB5002, AB5003, AB5004, AB5005,AB5006, AB5007, AB5008 No individual UDI, as this product is used only within convenience kits.
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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