Events

Retiro De Equipo (Recall) de Device Recall First Step Flexible Endoscope Bedside PreClean Kit, EP4.

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
    79402
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1182-2018
  • Fecha de inicio del evento
    2017-11-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162225
  • 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
    Affected lots may have exceeded its microbial limits.
  • Acción
    Cygnus sent an Recall Letter dated November 3, 2017. Actions Required: 1. Immediately discontinue distribution of First Steps EP-4 and EP-4D with the referenced lot numbers above (as applicable). 2. Determine if any stock of the First Steps EP-4 and EP-4D with the referenced lot numbers above (as applicable) remains in your inventory. 3. Please complete the attached form and return to Cygnus Medical as indicated. 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 the lots in the tables above between November 28, 2016 and January 11, 2017 with the letter provided. Once Cygnus Medical has received your completed form, if you have indicated you have any remaining product from these lots, we will issue a Return Goods Authorization, call tag, and/or FedEx/UPS account number. If you have questions regarding this matter, please contact Customer Service at 800-990-7489 or Quality Control at 203-488-4554 at x105 during business hours 8:30am-5:00pm Eastern Standard Time.

Device

Device Recall First Step Flexible Endoscope Bedside PreClean Kit, EP4.
  • Modelo / Serial
    EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A; and EP-4D Lot EXP20 l80520A
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution. .
  • Descripción del producto
    First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".
  • 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