Events

Retiro De Equipo (Recall) de Device Recall Routine Service Kits or Parts for HLD SYSTEM

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 Cenorin.

¿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
    55802
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0039-2011
  • Fecha de inicio del evento
    2010-06-07
  • Fecha de publicación del evento
    2010-10-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92352
  • 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
    Device, pasteurization, hot water - Product Code LDS
  • Causa
    The water level sensor switch in the medical device cleaning and high level disinfection systems (washer/pasteurizers) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. it could present a health risk of biological hazard because the medical devices are not being adequately cleaned or pasteurized.
  • Acción
    On June 7, 2010, firm, CENORIN, sent "URGENT: MEDICAL DEVICE RECALL" Initial Notification letter with Recall Response Form, Series 500 Water Level Check Instructions, and the Water Level Switch Upgrade Kit Instruction (service kit P/N # 082395-00) to their consignees. The firm also sent these documents in Spanish language to their foreign consignees. The letter describes the recall product as HLD Systems Medical Device Cleaning and High Level Disinfection Series 500 Washer/Pasteurizer-Model 540, Model 540HT and Model 520. Customers are advised to call the Customer Service at 1-800-426-1402 or e-mail the firm. The Initial Notification letter instructs consignees to conduct and quarantine the recall products and notify their sub-accounts (customers) if products have been further distributed. While waiting for a replacement kit, the consignees are asked to follow the Series 500 Water Level Check Instructions to perform a test to ensure the water tank is completely filled up the expected water level. The firm also advised the consignees to add a cautionary label on the product to avoid any sharp or bump impact that may create any externally induced vibration noise to the device. The firm is developing a replacement kit that should be ready to send out to their consignees by June 30, 2010. A response card would be also sent out with a new kit, and it is used to verify that the kit has been successfully implemented. If you have any questions, please email jbennett@cenorin.com or call 253-395-2400 or toll free: 1-800-426-1042.

Device

Device Recall Routine Service Kits or Parts for HLD SYSTEM
  • Modelo / Serial
    The routine service Kit # 082395-00 or Part # 030500-00. Kits do not contain serial number.  Four kits were distributed one each for Model 520 with Serial numbers 529701 and 520502 and for Model 540 with Serial numbers 549204 and 540607.  The remaining 18 kits were shipped to consignees who purchased several kits or parts for inventory or service purpose, and they are not known for what specific device.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution:USA and countries including: Costa Rica, Ecuador, Japan, Mexico, and Taiwan.
  • Descripción del producto
    The Routine Service Kit #082395-00 or Part #030500-00 for HLD SYSTEM and it is labeled in part: "HLD SYSTEMS ***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com". || Service Kit P/N: 082395-00 Series 500 Water Level Switch Upgrade Kit: The purpose of this service kit was to provide replacement parts for customers who had HLD Systems that were manufactured prior to 3/22/07.These systems were manufactured with old, old switches that have been obsolete and discontinued. Part P/N: 030500-00 Switch, Liquid Level: This part was sold by itself to a foreign consignee in Japan for inventory purposes only for regularly scheduled maintenance of a device or replacement of parts at the end of their normal life expectancy.
  • Manufacturer
    Cenorin

Manufacturer

Cenorin
  • Dirección del fabricante
    Cenorin, 6324 S 199th Pl Ste 107, Kent WA 98032
  • Source
    USFDA