Events

Retiro De Equipo (Recall) de Device Recall STERRAD 100S Cassette

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Advanced Sterilization Products.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    62925
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2337-2012
  • Fecha de inicio del evento
    2012-06-19
  • Fecha de publicación del evento
    2012-09-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-11-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112044
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Sterilizer, chemical - Product Code MLR
  • Causa
    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.
  • Acción
    Advanced Sterilization Products sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL) letter dated July 16, 2012 to all their customers who purchased the STERRAD 100S and STERRAD NX System cassettes. The letter informed the customers of the problem identified and the actions to be taken. For the STERRAD NX System cassettes, there should be no impact to the functionality of these affected cassettes. Although printing may be smeared, illegible, or missing, the packaging has multiple references to the information, and the cassettes should be usable despite any printing error. For the STERRAD 100S System cassettes, there is a chance that the barcode will be unreadable and the STERRAD 100S Sterilizer will not accept the cassette. Customers were instructed to complete and return the business reply card and packing slip that are included in the letter. Customers were instructed to contact Stericycle at (888) 406-9303 for additional labels. Customers with questions about the recall letter were instructed to contact Stericycle at (888) 406-9303.

Device

Device Recall STERRAD 100S Cassette
  • Modelo / Serial
    Product Code: 10113
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    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.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • Dirección del fabricante
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 92618-2346
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA