Events

Retiro De Equipo (Recall) de HLD Systems 600 Series Washer/Pasteurizer

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, LLC.

¿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
    80295
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2288-2018
  • Fecha de inicio del evento
    2018-04-09
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=165073
  • 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
    There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.
  • Acción
    On April 9, 2018, Cenorin telephoned customers and then followed-up with a formal letter titled URGENT MEDICAL DEVICE RECALL via email. To mitigate this quality issue, Cenorin has a Corrective Kit available to replace the existing terminal blocks in the Washer/Pasteurizer as the long-term solution. In the meantime, here is how you can help with the recall process: 1. Please immediately examine your inventory for the recalled Washer/Pasteurizers listed and quarantine them to prevent further distribution. In addition, if you have further distributed this product, please notify your customers immediately using the enclosed notice. 2. If the Washer/Pasteurizers does not exhibit any of the symptoms of failure as noted, continue to use the Washer/Pasteurizers as normal until the service can be completed. If the Washer/Pasteurizers exhibit any of the symptoms of failure, immediately cease its use and contact Cenorin immediately at recall@cenorin.com or call Technical Support at 800-426-1042 ext. 224. 3. Complete the Recall Acknowledgement & Response Form and return to Cenorin as noted on form via email to recall@cenorin.com within 5 business days. Response is required. Customers with questions, please email Cenorin at recall@cenorin.com or call 253-395-2400 or toll-free 800-426-1042, extension 236 during the hours of business Monday through Friday, 7:30AM to 4:30PM, Pacific Standard Time.

Device

HLD Systems 600 Series Washer/Pasteurizer
  • Modelo / Serial
    Serial Numbers: 611503, 611504, 611505, 611506, 611601, 611602, 611603, 611604, 611605, 611606, 611607, 611608, 611609 & 611610
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia and Taiwan
  • Descripción del producto
    HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V || Product Usage: || Clean and thermally disinfect medical devices using full immersion pasteurization
  • Manufacturer
    Cenorin, LLC

Manufacturer

Cenorin, LLC
  • Dirección del fabricante
    Cenorin, LLC, 6324 S 199th Pl, Suite 107, Kent WA 98032
  • Empresa matriz del fabricante (2017)
    Cenorin L.L.C.
  • Source
    USFDA