Events

Retiro De Equipo (Recall) de Device Recall Scimed ChoIce Floppy PTCA Guide Wire 182 cm

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 Symbiosis Corp..

¿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
    25512
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0592-03
  • Fecha de inicio del evento
    2002-11-19
  • Fecha de publicación del evento
    2003-02-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-04-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25947
  • 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
    Wire, Guide, Catheter - Product Code DQX
  • Causa
    Product is mislabled as a choice floppy guide wire when it is actually a choice es(extra support) guide wire.
  • Acción
    Recall Letters issued 11/19/2002 via Federal Express to 7 hospital accounts. Consignees were requested to fill out a response form and return product to their Quincy, MA facility.

Device

Device Recall Scimed ChoIce Floppy PTCA Guide Wire 182 cm
  • Modelo / Serial
    Individual pouch codes are coded catalog # 12132-01, batch 4785750 expiration date 2004-05 and the five pack outer boxes are coded: Catalog No. 12132-01, batch 4806821 expiration date 2004-5.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was distributed to hospitals in FL, MI, GA, OR, ID AND CT. 05.
  • Descripción del producto
    Product is a ChoICE 182 cm Guide Wire, intended to facilitate placement of balloon dilatation catheters and other therapeutic devices during Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures. The ChoICE guide wire contains a one-piece stainless steel core, which extends throughout the length of the wire and provides steerability and torqueability. The wire is tapered and formed at the distal tip. A radiopaque platinum spring coil surrounds the distal tip of the core wire. || The ChoICE Guide Wire is a single use, sterile (EO), device packaged in a carrier tube, which is held in a coil by plastic clips. The carrier tube assembly of the guide wire is sealed into a pouch. One side of the pouch is clear polyethylene/polyester laminate and the reverse side is Tyvek. The pouch assemblies are packaged in a five-pack product box. A flushing tool is included in the package to facilitate hydration of the coating with heparanized saline before use. || 1, page 1, is a copy of the pouch label. Exhibit 1, page 2 is a copy of the five-pack product box label. Exhibit 2 is a copy of the Directions for Use.
  • Manufacturer
    Symbiosis Corp.

Manufacturer

Symbiosis Corp.
  • Dirección del fabricante
    Symbiosis Corp., 8600 NW 41th Street, Miami FL 33166
  • Source
    USFDA