Events

Retiro De Equipo (Recall) de Device Recall Haemonetics 2380 MINI HandHeld Tube Sealer Power Source

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 Haemonetics Corporation.

¿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
    57855
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1899-2011
  • Fecha de inicio del evento
    2011-01-31
  • Fecha de publicación del evento
    2011-04-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97588
  • 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, Heat-Sealing - Product Code KSD
  • Causa
    Battery pack may have exposed wire becoming hot.
  • Acción
    The firm, Haemonetics, issued a "Field Notification: 2380 Sealer battery pack" letter dated January 28, 2011 to its customers. An international English version of this letter (CL101020-IE) has been released to foreign Distribution countries. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Record the manufacturing date of battery, equipment model, serial number, and photo of the affected battery. 2) Report the defect through the Haemonetics PIR system by emailing: sebra2380@haemonetics.com with all of the information listed including the appropriate contact information for their company. 3) Recycle or dispose of the nickel-cadmium (NiCad) battery pack in accordance with the local, state, federal, or country specific regulations. Under no circumstances should the battery pack be incinerated as this can cause explosion and personal injury. The operation manual will be updated to provide additional information about the proper installation and removal of the battery. This updated manual will be distributed with new devices upon release. Should you have any questions or concerns regarding this matter, please contact the firm at sebra2380@haemonetics.com.

Device

Device Recall Haemonetics 2380 MINI HandHeld Tube Sealer Power Source
  • Modelo / Serial
    All serial numbers
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries including: Australia, Austria, AEU, Belgium, Bangladesh, Canada, China, France, Germany, Hong Kong, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, New Zealand, Pakistan, Philippines, Singapore, Sri Lanka, Taiwan and Turkey.
  • Descripción del producto
    2380 MINI Hand-Held Tube Sealer Power Source || (including a 23802000 Battery Pack) || The Model 2380 Power Source is an instrument that generates RF power for making seals on tubing made of RF reactive thermoplastic materials typically used in blood banks, blood processing facilities and transfusion centers.
  • Manufacturer
    Haemonetics Corporation

Manufacturer

Haemonetics Corporation
  • Dirección del fabricante
    Haemonetics Corporation, 400 Wood Rd, Braintree MA 02184-2412
  • Empresa matriz del fabricante (2017)
    Haemonetics Corporation
  • Source
    USFDA