FDAFDA · Alimentos y medicamentos·N.º oficial Z-2212-2016
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.
Publicado el 3 de agosto 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
BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or organs
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Carefusion 2200 Inc
- Distribuidor
- Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
- Lote
- Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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