Events

Retiro De Equipo (Recall) de Device Recall First Step Endoscopic Cleaning Pad

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 Madison Polymeric Engineering.

¿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
    79826
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1896-2018
  • Fecha de inicio del evento
    2018-03-21
  • 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=163608
  • 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
    Accessories, cleaning brushes, for endoscope - Product Code MNL
  • Causa
    The products exhibit an unpleasant odor due to microbial contamination with yarrowia lipolytica.
  • Acción
    Notification letters were distributed on 3/21/18. The letters instructed customers to perform the following: 1. Immediately quarantine, and discontinue the use or distribution of First Step EP-3, EP-4, EP-6, 4" Button Brush EP-4B; Travel Kit TK200(W); and Draco Enzymatic Deep-Cleaning Pad HY0305Z with the referenced lot numbers specified in Table1. 2. Determine if any stock of the with the reference lot numbers specified in Table 1 remains in your inventory. We ask that you discard the product at your facility and document the quantity discarded on the form. Otherwise, we can issue you a Return Goods Authorization, call tag and/or Fed EX/UPS account number to have the product returned back to us. 3. Please complete the attached form and return to Cygnus Medical as indicated as soon as possible. It is important to notify Cygnus Medical whether or not your facility has any inventory of this product. 4. Please notify any of your customers who may have received lots with the referenced lot numbers specified in Table 1 with the letter provided. Your assistance is appreciated and necessary.

Device

Device Recall First Step Endoscopic Cleaning Pad
  • Modelo / Serial
    Lot Numbers: EX20181220P, EX20181221P, EX20181222P, EX20181226P, EX20181227P, EX20181228P, EX20181229P, EX20190102P, EX20190103P, EX20190105P, EX20190111P, EX20190112P
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI. The products were also distributed in Canada.
  • Descripción del producto
    First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4
  • Manufacturer
    Madison Polymeric Engineering

Manufacturer

Madison Polymeric Engineering
  • Dirección del fabricante
    Madison Polymeric Engineering, 965 W Main St, Branford CT 06405-3453
  • Empresa matriz del fabricante (2017)
    Madison Polymeric Engineering Inc.
  • Source
    USFDA