Events

Retiro De Equipo (Recall) de Device Recall Natura Durahesive ConvaTec Moldable Technology PostOperative /Surgical System (57 mm)

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 Convatec 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
    59952
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0013-2012
  • Fecha de inicio del evento
    2011-06-22
  • Fecha de publicación del evento
    2011-10-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104065
  • 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
    Collector, ostomy - Product Code EXB
  • Causa
    Post-operative kits 57 mm may contain 70 mm pouches.
  • Acción
    The firm, ConvaTec, sent a "MEDICAL DEVICE RECALL" letter dated June 22, 2011 via UPS 2nd day air to all customers and sales representatives that received product. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately stop distributing and quarantine the recalled lot; perform a count of recalled product currently in inventory; complete and return the Recall Response Form via fax to (908) 904-2120 or mail to 200 Headquarters Park Drive, Skillman, New Jersey 08558; return the Recall Response Form even if no recalled product is in inventory; call the toll free number 1-800-582-6514 for return instructions and RGA number-(recall product must be returned in a separate container from any other product returns); mark all return shipments "Recalled Product" and provide supplied RGA number, and forward this letter to customers, if they distributed the product. Should you have any questions, call 1-800-582-6514.

Device

Device Recall Natura Durahesive ConvaTec Moldable Technology PostOperative /Surgical System (57 mm)
  • Modelo / Serial
    Lot 1C00776 No 510K since this is Class I exempt.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: AL, AZ, CA, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX and UT.
  • Descripción del producto
    Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) || Required for application to a patient immediately after ostomy surgery.
  • Manufacturer
    Convatec Inc.

Manufacturer

Convatec Inc.
  • Dirección del fabricante
    Convatec Inc., 200 Headquarters Park Drive, Skillman NJ 08558-2600
  • Empresa matriz del fabricante (2017)
    Triona Holding Sa
  • Source
    USFDA