FDAFDA · Alimentos y medicamentos·N.º oficial Z-1468-2014
CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories 82-8804 In Line Valve only with SIPHONGUARD Device 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories 82-8850 Certas Therapeutic Management System
Publicado el 23 de abril de 2014 · Inicio del retiro: 13 de diciembre de 2013
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
Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Codman & Shurtleff, Inc.
- Distribuidor
- Nationwide Distribution.
- Lote
- All serial numbers
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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