Events

Retiro De Equipo (Recall) de Device Recall CIDEX

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
    71708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2459-2015
  • Fecha de inicio del evento
    2015-07-27
  • Fecha de publicación del evento
    2015-08-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-07-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138798
  • 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
    Sterilant, medical devices - Product Code MED
  • Causa
    Advanced sterilization products (asp) is recalling the cidex activated dialdehyde solution because it may lack the adequate data to support the entire 24-month shelf life.
  • Acción
    A Urgent Product Notification Letter dated July 27, 2015, will be sent to customers and distributor who purchased the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24 month shelf life. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the requested information on the enclosed postage paid Business Reply Card and return it to Stericycle. Customers with questions or need additional packing labels are instructed to contact Stericycle at (877) 550-0701, M-F, 8am-5pm ET. Customers are instructed to report complaints or suspected problems with CIDEX Activated Dialdehyde Solution by contacting (888) 783-7723.

Device

Device Recall CIDEX
  • Modelo / Serial
    210813065 210813066 220813066 230813067 270813067 270813068 270813069 280813069 280813070 290813070 021013082 031013082 031013083 031013084 041013084 071013084 071013085 111013090 111013091 141013091 231013091 241013091 241013092 281013093 060114109 070114109 290114001 300114001 300114002 100214003 100214004 110214004 130214004 010414020 010414021 250314017 260314017 260314018 270314018 270314019 310314019 310314020 070514029 120514029 120514030 130514030 140514030 010714048 300614047 020714048 020714049 030714049 090914066 100914066 110914066 110914067 150914067 160914068 170914068 170914069 021014077 231014084 231014085 271014085 271014086 281014086 201114092 211114092 091214099 091214100 150115006 160115006 220115006 220115007 230115007 100215012 110215012 110215013 050515029 050515030 060515030 070515031
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (nationwide) Distribution
  • Descripción del producto
    CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
  • 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