Events

Retiro De Equipo (Recall) de Device Recall Mountain First Aid Kit

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
    60041
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0122-2012
  • Fecha de inicio del evento
    2011-07-07
  • Fecha de publicación del evento
    2011-10-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104291
  • 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
    First aid kit with drug - Product Code LRR
  • Causa
    The first aid kits are recalled because the kits contain iodine prep pad single use wipes which were recalled by triad.
  • Acción
    Lifeline First Aid, LLC sent a " PRODUCT RECALL NOTICE-LIFELINE FIRST AID KITS WHICH INCLUDE H & P [TRIAD] PVP IODINE WIPES" letter dated July 7, 2011 to all affected customers. The letter states that Lifeline First Aid, LLC has become aware of a recall of Povidone Iodine Wipes manufactured by H&P; Industries Inc. (TRIAD GROUP) and marketed under various brand names, including Triad and Swift. The recall of the Povidone Iodine Wipe is due to potential microbial contamination of the product. The letter instructs customers to collect and quarantine all affected products and to complete and return an attached Customer Response Form via fax to (503) 783-3721. Affected products will be replaced without charge and acceptable Lifeline first aid kits will be re-worked and returned using Lifeline's standard RGA process. Customers may call Lifeline customer service at 1 (877) 377-8243 for further instructions.

Device

Device Recall Mountain First Aid Kit
  • Modelo / Serial
    no codes.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Mountain First Aid Kit, Part Number 4118; UPC 0-91966-04118-3, contains 88 Pieces. || The kit is labeled in parts: "***MOUNTAIN FIRST AID KIT***MODEL 4118*** || 1 IODINE PREP PADS***Lifeline First Aid, LLC***Wilsonville, OR 97070, USA***www.lifelinefirstaid.com***". || First aid kit.
  • Manufacturer
    Lifeline First Aid LLC

Manufacturer

Lifeline First Aid LLC
  • Dirección del fabricante
    Lifeline First Aid LLC, 26200 SW 95th Ave Ste 301, Wilsonville OR 97070-8204
  • Source
    USFDA