FDAFDA · Alimentos y medicamentos·N.º oficial Z-2337-2012
STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD Cassettes are used in conjunction with the STERRAD Sterilizers, and each cassette model is for use only in the matching sterilizer model.
Publicado el 19 de septiembre 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
Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Advanced Sterilization Products
- Distribuidor
- Nationwide Distribution.
- Lote
- Product Code: 10113
- Clasificación de riesgo
- Class III
- Área (FDA)
- device
- País
- United States
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