FDAFDA · Alimentos y medicamentos·N.º oficial Z-2669-2017
Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and equipment out of reach or they interface an EP catheter with the appropriate external stimulation of recording equipment.
Publicado el 12 de julio de 2017 · Inicio del retiro: 8 de mayo de 2017
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation Cables because Sterilmed determined that the cables are Class III devices and thus require, but do not currently have, premarket review and approval.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Sterilmed Inc
- Distribuidor
- US Distribution to the states of : AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA WI and WV.
- Lote
- all lots
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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