FDAFDA · Alimentos y medicamentos·N.º oficial Z-2832-2016
The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
Publicado el 21 de septiembre de 2016 · Inicio del retiro: 1 de julio de 2016
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
The seal between the balloon and the housing may leak.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Circulatory Technology Inc
- Distribuidor
- US Distribution to states of: LA, MI, NY, OH, OR & TX.
- Lote
- Lot # 014648 USE BY: 09/01/2018
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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