Events

Retiro De Equipo (Recall) de Device Recall Lifeline Brand

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 Lifeline First Aid 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
    74329
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2132-2016
  • Fecha de inicio del evento
    2016-05-16
  • Fecha de publicación del evento
    2016-07-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147206
  • 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
    Valve, non-rebreathing - Product Code CBP
  • Causa
    First aid kits or rescue kits are recalled because they contains the cpr shield with one way valve and barrier filter (mask) and this mask is cleared only for prescription use and is not cleared for over-the-counter (otc) use.
  • Acción
    The firm sent the PRODUCT RECALL NOTICE- LIFELINE FIRST AID KITS WHICH INCLUDE CPR MASK letter, dated 5/11/2016, to their consignees. CPR shields will be replaced without charge and acceptable Lifeline First Aid kits will be re-worked and returned using our standard RGA process. In addition, the firm sent the PRODUCT RECALL NOTICE- CADILLAC FIRST AID KIT letter, dated May 31, 2016, to General Motors. General Motors will be sending out a dealership bulletin to inform their customers of this issue. Once confirmed, replacement masks will be sent to the requested dealerships and made available to be ordered (at no cost) as needed. Please complete and fax the attached Customer Response Form to Lifeline at (503)783-3721. Consignees with questions should call Lifeline First Aid, LLC at (503)783-3660.

Device

Device Recall Lifeline Brand
  • Modelo / Serial
    item #4042 and item #4043 have the expiration date: 11/30/2017.  Item #4037 has the following lots and expiration dates: Lot # Expiration Date 101483; 3/15 101546; 6/15 101682; 7/15 101804; 1/16 101812; 1/16 102032; 5/16 102109; 5/16 102098; 5/17 102130; 5/16 102296; 10/16 102317; 10/16 102295; 10/16 102372; 1/17 102638; 1/17 102694; 8/17
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in AZ, CA, CO, FL, GA, IL, KY, MD, MN, MO, MT, NE, NJ, NY, OK, OR, PA, SC, TN, UT, VA, WA, WA, and WI. Also distributed in New Zealand.
  • Descripción del producto
    Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. || Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline. || UPC Red color kit: 845174005464; || UPC Lime color kit: 845174005594; || UPC Purple color: 845174005600; || UPC of master case of 6 845174005471 (2 each color) || Item # 4037, Outfitter First Aid Kit, CPR shield with one way valve & barrier filter, brand Lifeline, UPC 845174003453
  • Manufacturer
    Lifeline First Aid LLC

Manufacturer

Lifeline First Aid LLC
  • Dirección del fabricante
    Lifeline First Aid LLC, 26200 SW 95th Ave Ste 302, Wilsonville OR 97070-8204
  • Empresa matriz del fabricante (2017)
    Lifeline First Aid Llc
  • Source
    USFDA