Events

Retiro De Equipo (Recall) de Device Recall STRIP T'S Sterile Adhesive Organizer

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 Kapp Surgical Instrument 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
    60000
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0068-2012
  • Fecha de inicio del evento
    2008-03-05
  • Fecha de publicación del evento
    2011-10-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104215
  • 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
    Drape, adhesive, aerosol - Product Code KGT
  • Causa
    A portion of the labeled expiration date is missing. the expiration date on approximately half of the pouch labels distributed are missing the last digit of the year of expiration. however, the shelf box containing the pouches is labeled correctly.
  • Acción
    Surgical Concepts, Inc ( A subsidiary of Kapp Surgical Instrument Inc) sent a notification letter dated March 5, 2008, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm ceased distribution of the suspect product on December 5, 2007. The letter informs the firm's customers (both distributors and medical user/customers) of the expiration date labeling omission of the last digit of the year of expiration. It goes on to explain that the incomplete expiration date is present on the individual packages only and that the shelf boxes are labeled correctly with the complete/correct expiration date. The letter provides the customers with a contact person and a toll free telephone number 1-(800) 282-5277, to call in order to make arrangements for receive replacement labels for any misbranded packages received.

Device

Device Recall STRIP T'S Sterile Adhesive Organizer
  • Modelo / Serial
    Model #SC5000-4R, Lot #090710, Expiration Date: 2009-10
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution-- including the states of AK, CA, CO, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MT, NC, NM, OH, PA, TN, TX, UT, and VA
  • Descripción del producto
    STRIP T's STERILE ADHESIVE ORGANIZER, Model #SC5000-4R, Lot #090710, 510(k) exempt. One (1) adhesive organizer is packed in a Tyvek pouch and 60 pouches are placed into a 'Shelf Box'. The shelf box is placed into a shipping container. || The Sterile Adhesive Organizer is used to hold tubing or instruments to the drape in surgery.
  • Manufacturer
    Kapp Surgical Instrument Inc

Manufacturer

Kapp Surgical Instrument Inc
  • Dirección del fabricante
    Kapp Surgical Instrument Inc, 4919 Warrensville Center Rd, Warrensville Heights OH 44128-4353
  • Empresa matriz del fabricante (2017)
    Kapp Surgical Instrument Inc.
  • Source
    USFDA