FDAFDA · Alimentos y medicamentos·N.º oficial Z-0397-2014
CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Catalog No. 46026. CSF-Unitized Shunt Kits are designed as integrated CSF-Flow Control Shunts for use in shunting cerebrospinal fluid from the lateral ventricle of the brain into the peritoneal cavity.
Publicado el 4 de diciembre de 2013 · Inicio del retiro: 18 de noviembre 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
Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Medtronic Neurosurgery
- Distribuidor
- Worldwide Distribution - USA (nationwide) and Internationally to US and worldwide: Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, United Arab Emirates, United Kingdom.
- Lote
- Lot Numbers: Catalog No. 46022: D27162; D30984; D3461 0; D35834; D37761; D39054; D39539. Catalog No. 46024: D13944; D14093; D14217; D14216; D33526; D39540. Catalog No. 46026: D35572; D39583.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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