Events

Retiro De Equipo (Recall) de ArcticGel Pads

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..

¿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
    78664
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0271-2018
  • Fecha de inicio del evento
    2017-10-16
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160082
  • 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
    System, thermal regulating - Product Code DWJ
  • Causa
    Hydrogel peeling from the pads.
  • Acción
    Bard Medical sent an Urgent: Medical Product Recall letter on October 16, 2017 to all affected customers. Instructions: 1. Check all inventory locations within your institution for ARCTICGEL" Pad(s) Your facility may have received at least one Medivance ARCTICGEL" Small Pad Kit, product code 317-05, with the lot code NGBS1063. Please refer to the diagram on Attachment 1 to help you locate the product number and lot number of your ARCTICGEL" Pad(s). Please remove any identified affected product(s) from your shelves and complete steps 2-4 below. 2.Do not further use any affected product(s) 3. If you have unused affected product(s) for return: a. Fill out the Customer Recall and Effectiveness Check Form  Write in the product(s) number and affected lot(s) number (product code 317-05, lot number NGBS1063) in the table provided along with quantities of each, then complete the bottom of the form with your facilitys information. b. Call or email the recall coordinator (using the contact information on the form) to obtain an RCL number to include on the Customer Recall and Effectiveness Check Form. Return the form to the recall coordinator via FAX: 1-770-784-6469 or E-MAIL: bmd.recall@crbard.com). If you cannot Fax or E-mail the form, please call 1-800-793-8110 and report the required information verbally. c. Upon receipt of the Recall & Effectiveness Check Form, the Recall Coordinator will issue you a FedEx shipping label and instructions for the return of the affected product(s). Please mark the outside package as RECALLED PRODUCT and include the RCL number. All product(s) should be returned to the following shipping address. d. BMD will provide replacement products at no charge for your returned, unused, affected product(s) (ARCTICGEL" Small Pad Kits, product code 317-05, lot number NGBS1063). 4.If you have No Affected Product available for return: No further action is needed. BARD¿ ARCTICGEL" Pad lot codes that are not part of affected lot NG

Device

ArcticGel Pads
  • Modelo / Serial
    Product Code: 31705 Lot # NGBS1063
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : FL, LA, IL, CA, MO, MN, TX, OK, TN, and NY
  • Descripción del producto
    Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. || Is a Thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.¿
  • Manufacturer
    C.R. Bard, Inc.

Manufacturer

C.R. Bard, Inc.
  • Dirección del fabricante
    C.R. Bard, Inc., 8195 Industrial Blvd NE, Covington GA 30014-1497
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA