FDAFDA · Alimentos y medicamentos·N.º oficial Z-0464-2013
Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
Publicado el 12 de diciembre de 2012 · Inicio del retiro: 8 de junio 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
Custom Procedural trays contain Stryker Hytrel Togas which are being recalled because the clear tape that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Merit Medical Systems, Inc.
- Distribuidor
- Nationwide distribution: US including states of: NE and SD.
- Lote
- Merit's Custom Total Hip Pack, K12T-05537, Lot numbers T320054, T331364, T335090; Merit's Total Knee Pack, K12T05538, Lot numbers T320059, T331365, T335092
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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