Events

Retiro De Equipo (Recall) de Device Recall Bard Foley procedural trays packaged in breather bags

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 C.R. Bard, Inc., Urological Division.

¿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
    62774
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2327-2012
  • Fecha de inicio del evento
    2012-06-29
  • Fecha de publicación del evento
    2012-09-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111691
  • 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
    Catheter coude - Product Code EZC
  • Causa
    Incomplete seal on sterile packages of product.
  • Acción
    C. R. Bard Inc, sent a Urgent Product Recall Notification letter dated June 27. 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This notification is being sent because there is a potential for a limited number of units within the subject lots (noted above) that may contain an open seal of the sterile packages. The issue is visually obvious even before the package is opened. No patient injury or adverse events have been reported. Do not use or further distribute any of the affected products. Once the product affected by tlle recall has been removed from your inventory 1.Fill out the Recall & Effectiveness Check Form. Be sure to state the quantities affected of the recalled product that you have in stock. It is extremely important that we receive this information. 2. Fax the Recall & Effectiveness Check Form to BMD at 1-770-784-6469. The Recall Coordinator will issue you with a Return Authorization (RCL) to facilitate the expedient return and replacement of the product. 3. A mailing label is enclosed for your convenience to return the affected product. Please mark the outside package as "RECALLED PRODUCT" and include the RCL number. All products should be retumed to the following shipping address that is in the letter.

Device

Device Recall Bard Foley procedural trays packaged in breather bags
  • Modelo / Serial
    Catalog No. 300316A (Lot Nos. - NGVJ1108, NGVJ1712, NGVJ1713, NGVJ1105, NGVJ1714) Catalog No. 898316 (Lot Nos. NGVJ1614, NGVJ1615, NGVJ1616, NGVJ1617) Catalog No. 897414 (Lot No. NGVJ1705) Catalog No. 907618 (Lot No. NGVJ1757) Catalog No. 907600 (Lot No. NGVJ1764)
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA
  • Descripción del producto
    Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. || Used to catheterize patients. The finished trays are sold in Tyvek breather bags.
  • Manufacturer
    C.R. Bard, Inc., Urological Division

Manufacturer

C.R. Bard, Inc., Urological Division
  • Dirección del fabricante
    C.R. Bard, Inc., Urological Division, 8195 Industrial Blvd Ne, Covington GA 30014-1497
  • Source
    USFDA