Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
Publicado el 3 de abril de 2013 · Inicio del retiro: 4 de marzo 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
An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. The labeling of the product codes identified above state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- CareFusion 213, LLC
- Distribuidor
- USA Nationwide Distribution
- Lote
- Tincture Packaged: Product Number 260619 and Product ID D086353; Tincture 3,000 Bulk: Product Number 260520 and Product ID D086353.
- Clasificación de riesgo
- Class III
- Área (FDA)
- device
- País
- United States
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