FDAFDA · Alimentos y medicamentos·N.º oficial Z-0098-2018
STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box. Some of the pouches inside of cardboard box are incorrectly labeled as Catalog number 20400162S, High Flow Insufflation Tubing (with filter) For 26432020-1 THERMOFLATOR. The firm name on the label is Karl Storz Endoscopy-America, Inc., El Segundo, CA.
Publicado el 22 de noviembre de 2017 · Inicio del retiro: 10 de octubre de 2017
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
The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Karl Storz Endoscopy
- Distribuidor
- Distribution was made nationwide. There was government distribution and no military distribution. Foreign distribution was made to Canada.
- Lote
- Lot #129241
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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