Events

Retiro De Equipo (Recall) de Device Recall Nonsterile Viscot Part Number 1437100 Surgical Skin Markers

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 Precision Dynamics Corporation.

¿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
    65724
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1872-2013
  • Fecha de inicio del evento
    2013-07-10
  • Fecha de publicación del evento
    2013-08-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119963
  • 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
    skin markers - Product Code FZZ
  • Causa
    Pdc healthcare initiated this recall of non-sterile viscot part number 1437-100 surgical skin markers, becuase they were inadvertently mislabeled as pn ster-vis sterile skin marker pen with labels and flex ruter.
  • Acción
    Precision Dynamics Corp. (PDC) sent a Urgent: Skin Marker Pen Recall letter dated July 10, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. All affected customers have also been contacted by phone and email as of July 12, 2013 We want to take every precaution to ensure patient safety. 1. Immediately examine your inventory 2. Quarantine the product subject to recall 3. Complete and return the enclosed response form as soon as possible Your PDC Healthcare customer service representative will contact you directly to arrange the return of the product. In addition, if you may have distributed this product, please identify your customers and notify them at once of this product recall. Your customer notification may be enhanced by including a copy of this recall notification letter. If you have any questions please call the PDC Healthcare Returns Department at 800-435-4242 ext. 5003. Thank you for your understanding and assistance related to this matter.

Device

Device Recall Nonsterile Viscot Part Number 1437100 Surgical Skin Markers
  • Modelo / Serial
    Part Number: PDC PN STE-VIS (Viscot PN 1437-100)  Lot: 061313.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution including the states of SC, TX, TN, WA, OK.
  • Descripción del producto
    Non-sterile Viscot Surgical Skin Markers || Part Number 1437-100 || Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement; available in nonsterile configuration.
  • Manufacturer
    Precision Dynamics Corporation

Manufacturer

Precision Dynamics Corporation
  • Dirección del fabricante
    Precision Dynamics Corporation, 27770 Entertainment Dr, Suite 200, Valencia CA 91355
  • Empresa matriz del fabricante (2017)
    Precision Dynamics Corporation
  • Source
    USFDA