FDAFDA · Alimentos y medicamentos·N.º oficial Z-2200-2012
13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.
Publicado el 22 de agosto de 2012 · Inicio del retiro: 17 de julio de 2012
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
BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. This mislabeling was discovered on 29-June-2012 during a clinical case.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Nico Corp.
- Distribuidor
- Worldwide Distribution - USA including MI and Canada
- Lote
- REF: NN-8011 - LOT: 80344-TD00214 (manufactured on 11-April-2012)
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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