Events

Retiro De Equipo (Recall) de SURFIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar

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
    78507
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0525-2018
  • Fecha de inicio del evento
    2017-10-26
  • 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=159675
  • 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
    Ostomy care kit - Product Code PQE
  • Causa
    A portion of lot 7h02242 outer boxes (market units) of the sur-fit natura moldable durahesive skin barrier (10 pack, 45 mm, ref 411802) were incorrectly labeled as natura moldable stomahesive skin barrier (10 pack, 45 mm, ref 411803).
  • Acción
    Customers were notified of the recall via Urgent: Voluntary Medical Device Recall letters on approximately 10/26/2017. The letter identified the affected device and the reason for the recall. The letter also provided instructions for distributors, retailers, and end users. End Users are to 1.) Inspect all shippers of 411802 (Durahesive), and all loose market units of 411803 (Stomahesive) to confirm whether affected product is under their control; 2.) Perform a count of affected product currently in inventory and complete and return the enclosed response form to the address provided; 3.) If customers have any affected product in inventory they are to contact cic@convatec.com or call the Customer Interaction Center at the toll free number 1-800-422-8811 for further instructions regarding how to return affected product and receive correctly labeled replacement product.

Device

SURFIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar
  • Modelo / Serial
    Lot 7H02242
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution - AK, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, and WI.
  • Descripción del producto
    SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. || Intended for use as an ostomy protector providing a protective barrier to patient skin.
  • Manufacturer
    ConvaTec, Inc

Manufacturer

ConvaTec, Inc
  • Dirección del fabricante
    ConvaTec, Inc, 7900 Triad Center Dr Ste 400, Greensboro NC 27409-9076
  • Empresa matriz del fabricante (2017)
    Triona Holding Sa
  • Source
    USFDA