FDAFDA · Alimentos y medicamentos·N.º oficial Z-2390-2021
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
Publicado el 8 de septiembre de 2021 · Inicio del retiro: 23 de julio de 2021
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
Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Aspen Surgical Products, Inc.
- Distribuidor
- US nationwide distribution. No foreign distribution.
- Lote
- All lots manufactured between July 9, 2019 to July 9, 2021
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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