Events

Retiro De Equipo (Recall) de Device Recall Tyvek SelfSeal Pouch with STERRAD Chemical Indicator

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
    56367
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1393-2011
  • Fecha de inicio del evento
    2010-06-23
  • Fecha de publicación del evento
    2011-02-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93317
  • 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
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories - Product Code KCT
  • Causa
    The recall was initiated after advanced sterilization products (asp) discovered a non-conforming lot. the misaligned perforations may have caused the seal to be incomplete on some of the pouches, creating a potential breach for pouches being used to store sterilized equipment on shelves.
  • Acción
    Advanced Sterilization Products (ASP) released Urgent: Product Recall notifications to its consignees identifying the affected product and explaining the reason for recall. The letter also discussed the impact of using this affected product and return instructions. The firm asked customers to examine their inventory, discontinue use of Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332 and to return all unused affected products to Stericycle. Customers are to complete the Business Reply Card and return it to Stericycle.

Device

Device Recall Tyvek SelfSeal Pouch with STERRAD Chemical Indicator
  • Modelo / Serial
    Lot Number: 2020
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Argentina, Australia, Canada, Chile, Czech Republic, Hong Kong, India, Japan, Panama, Peru and Puerto Rico.
  • Descripción del producto
    Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. || Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

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