Events

Retiro De Equipo (Recall) de DualCap Solo

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 Catheter Connections, Inc..

¿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
    69066
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2595-2014
  • Fecha de inicio del evento
    2014-08-05
  • Fecha de publicación del evento
    2014-09-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129487
  • 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
    Pad, alcohol, device disinfectant - Product Code LKB
  • Causa
    Catheter connections is recalling dualcap iv pole strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile.
  • Acción
    The firm, Catheter Connections, sent an "Urgent: Medical Device Field Action" letter dated August 5, 2014 to its consignees/customers. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to identify any customers who received this product having lot no. 1406509; make all potential users in your facility are made aware of this notification and the recommended actions; forward the attached URGENT MEDICAL DEVICE CORRECTION LETTER to customers immediately via fax or email; search your inventory and instruct all users to check each cap coming from the specific affected lot; quarantine and discard any defective product; and complete and return the attached URGENT MEDICAL DEVICE FIELD ACTION REPLY FORM via fax to 1-888-862-2693 or email to: info@cathconn.com. Catheter Connections does not require the return of devices having the affected lot number. If you have questions, please contact Catheter Connections at 1-801-906-0820 (M-F, 8:00 am - 5:00 pm MST) and ask for Quality Department.

Device

DualCap Solo
  • Modelo / Serial
    Lot 1406509
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: CT, GA, MD, and PA. .
  • Descripción del producto
    DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. || When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
  • Manufacturer
    Catheter Connections, Inc.

Manufacturer

Catheter Connections, Inc.
  • Dirección del fabricante
    Catheter Connections, Inc., 615 Arapeen Dr Ste 302A, Salt Lake City UT 84108
  • Empresa matriz del fabricante (2017)
    Merit Medical Systems Inc
  • Source
    USFDA