Events

Retiro De Equipo (Recall) de Device Recall Ventlab Manual Resuscitators

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 Ventlab LLC.

¿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
    68242
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1948-2014
  • Fecha de inicio del evento
    2014-05-16
  • Fecha de publicación del evento
    2014-07-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-11-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127204
  • 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
    Ventilator, emergency, manual (resuscitator) - Product Code BTM
  • Causa
    The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.
  • Acción
    The firm, Ventlab, issued a press dated May 14, 2014, stating Ventlab, LLC has initiated a voluntary medical device removal of a limited number of Ventlab" Resuscitator Bags. The bag series and lot numbers were included in a table as well as manufacture dates. In addition, Ventlab, LLC sent an "URGENT: MEDICAL DEVICE PRODUCT REMOVAL IMMEDIATE ACTION REQUIRED" letter dated May 19, 2014 to its distributors and customers. The letter described the product, problem and actions to be taken. The customers were instructed to review and examine their inventory for affected product; stop using them and immediately contact Ventlab, LLC for further instructions on the return of these products; and if product was further distributed, identify their customers/consignees and notify them of this product removal. The customers were also instructed to complete and return the attached Return Response Form via fax at 1-800-400-8820, Attn: Quality Department, or email to: PFA@ventlab.com as soon as possible and inform all affected personnel of this removal. Ventlab will send new corrected replacement resuscitation bags to customers once you return the affected product. If you have any questions regarding this action, please call Ventlab at 1-800-237-5481 between the hours of 8:30 AM to 5:00 PM (EST) Monday through Friday, or 1-844-635-5326 or via e-mail at PFA@ventlab.com.

Device

Device Recall Ventlab Manual Resuscitators
  • Modelo / Serial
    Manual Resuscitator Bag Series: AF1000, AF2000, AF5000, BT4000, VN2000, VN5000, VT1000; Lot #s105147 -107609. AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, PRO-1900, SC7000, SC8120, SS3200, VN2000, VN3000, VN4000, VN5000; Lot #s 106245 -107291. VN2102; Lot #200349. AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM2000, CPRM3000, PRO-1000, PRO-2000, SC7000, SC8020, VN2000, VN3000, VN4000; Lot #s 107029 -107634. VN2002; Lot # 200492. SC8000, SC9000; Lot #s 101441 -107461. CPRM1000; Lot #s 99523 -107315.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of OH, NY, TX, TN, FL, CT, and VA,
  • Descripción del producto
    Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, VN2000, VN3000, VN4000, VN5000, VT1000 , VN2102, VN2002. Emergency manual resuscitator for the Pediatric Population.
  • Manufacturer
    Ventlab LLC

Manufacturer

Ventlab LLC
  • Dirección del fabricante
    Ventlab LLC, 2710 Northridge Dr Nw, Suite A, Grand Rapids MI 49544-9112
  • Empresa matriz del fabricante (2017)
    Ventlab Llc
  • Source
    USFDA