Events

Retiro De Equipo (Recall) de Device Recall CIVCO SurgiTip Transducer Cover, REF 610833

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 Civco Medical Instruments 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
    70719
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1400-2015
  • Fecha de inicio del evento
    2015-02-26
  • Fecha de publicación del evento
    2015-04-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134563
  • 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
    Transducer, ultrasonic, diagnostic - Product Code ITX
  • Causa
    Leaks were detected in the recalled lot which may compromise the sterility of the product.
  • Acción
    On 3/12/2015, the Urgent Medical Device Recall notice was emailed to all of the affected customers. The notice identified the affected product and stated that the sterile covers from the affected manufacturing lot were not meeting quality levels and may leak. Customers were requested to return all of surgi tip covers from the production lot identified for replacement. To schedule the return and arrange for replacement product to be sent, customers were asked to contact Ms. Amy King, Customer Service Team Leader at 319-248-6520 or info@civco.com.

Device

Device Recall CIVCO SurgiTip Transducer Cover, REF 610833
  • Modelo / Serial
    Tyvek pouch - lot M591280; Box lot - M612600 Expiration date 2018.01
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to the states of CA, IL, MA, MI, MO, and WI.
  • Descripción del producto
    CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12. Rx only. || The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity and intra-operative diagnostic ultrasound.
  • Manufacturer
    Civco Medical Instruments Inc

Manufacturer

Civco Medical Instruments Inc
  • Dirección del fabricante
    Civco Medical Instruments Inc, 102 1st St S, Kalona IA 52247-9589
  • Empresa matriz del fabricante (2017)
    Roper Technologies Inc
  • Source
    USFDA