FDAFDA · Alimentos y medicamentos·N.º oficial Z-1740-2024
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each catheter. The rotating hemostasis valve is typically y shaped with a female luer lock and a manual hemostasis valve. The female port allows for aspiration and contrast injections while the hemostasis valve allows direct arterial access when using other devices such as guidewires and/or interventional devices.
Publicado el 8 de mayo de 2024 · Inicio del retiro: 3 de abril de 2024
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
Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Stryker Neurovascular
- Distribuidor
- US Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA, MI, MS, SC, IL.
- Lote
- UDI-DI: 07613327313895, Lot: 0000486382, Expiration: 17-Jul-2025
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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