FDAFDA · Alimentos y medicamentos·N.º oficial Z-1961-2012
Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the sterilization process. Specifically this tray is used for arthroscopes and arthroscopic hardware devices. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held.
Publicado el 18 de julio de 2012 · Inicio del retiro: 19 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
The gravity steam, Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed from the "Instructions for Use"; due to the firm's evaluation that identified original validation was not done at worst case conditions.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Stryker Endoscopy
- Distribuidor
- Worldwide Distribution--USA (nationwide)
- Lote
- All serial/lot numbers
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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