Events

Retiro De Equipo (Recall) de Device Recall Distributed under various trade names

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 First Aid Only Inc.

¿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
    46198
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0853-2008
  • Fecha de inicio del evento
    2007-12-10
  • Fecha de publicación del evento
    2008-02-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66950
  • 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 Kits - Product Code LRR
  • Causa
    Failed usp impurity testing: the ibuprofen supplied by its own manufacturer, used in these first aid kits, tablet refills, and cabinets, is being recalled for failing its usp limits for impurities during stability testing.
  • Acción
    The firm issued an Urgent Device Recall letter dated 10/10/07 to consignees receiving any of the products. The letter instructs consignees to return any recalled product to the firm. If any recalled prdoucts were further distributed, the consignee was requested to notify those consignees and have product returned.

Device

Device Recall Distributed under various trade names
  • Modelo / Serial
    Lot Numbers are for kits and cabinets: C0207, C0217, C0227, C0267, C0277, C0287, C0297, C0307, D0027, D0037, D0047, D0057, D0067, D0097, D0107, D0117, D0127, D0137, D0167, D0177, D0187, D0197, D0207, D0247, D0267, E0027, E0047, E0077, E0087, E0177, E0187, D0227, E0297, E0307, E0317, F0017, F0087, F0207, F0267, G0067, G0097, G0137, G0187, G0257, H0017, H0157, H0167, H0237, H0277, H0287, H0297, H0307, H0317, I0047, I0057, I0107, I0127, I0137, I0177, I0187, I0197, I0207, I0217, I0247, I0251, I0277, I0287, J0017, J0037, J0047, J0087, J0097, and J0117.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    Worldwide: USA and to one distributor in Dubai, United Arab Emirates.
  • Descripción del producto
    First Aid Kits, soft canvas, plastic, and metal containers holding various products to include ibuprofen and other first aid supplies, in various sizes. Kits include: || Labeled with First Aid Only, Inc. Vancouver, WA: || Recreational Sports First Aid, Item SM-134; || Welder's First Aid Kit, Item 253-U; || Vehicle First Aid Kit, Item 220-0; || On-The-Road Auto First Aid, Item FAO-310; || Auto First Aid Essentials, Item FAO-340; || Auto First Aid Essentials, Item FDA-532; || Auto First Aid Essentials, Item FDA-552; || Vehicle First Aid Kit, Item 221-U; || Outdoor First Aid Kit, Item FAO-410; || Outdoor First Aid Kit, Item FAO-410 || Outdoor First Aid Kit, Item FAO-420; || Outdoor First Aid Kit, Item FAO-430; || Outdoor First Aid Kit, Item FAO-440; || First Aid & Survival Kit, Item FA-462; || First Aid Kit, FAO-422-06; || First Aid Kit, 403-PC; || First Aid Response Kit, FA-504; || All Purpose First Aid Kit, Item FAO-112; || All Purpose First Aid Kit, Item FAO-122; || All Purpose First Aid Kit, Item FAO-142; || All Purpose First Aid Kit, Item FAO-432; || All Purpose First Aid Kit, Item FAO-444; || All Purpose First Aid Kit, Item FAO-452; || First Aid Essentials, Item FAO-130; || First Aid Essentials, Item FAO-132; || First Aid Essentials, Item FAO-134; || First Aid Essentials, Item FAO-422; || First Aid Essentials, Item FAO-428; || First Aid Essentials, Item FAO-432; || First Aid Essentials, Item FAO-442; || Refillable First Aid Kit, FAO-490C; || Refillable First Aid Kit, FAO-490C; || Brite Stock first aid kits (only labeled on shipping case as being manufactured by First Aid Only): || Item FAO-130-BS; || Item FAO-132-BS; || Item FAO-134-BS; || Manufactured by First Aid Only, Inc. Vancouver, WA. Distributed by Wholesale Merchandisers, Inc., Grand Rapids, MI 49544: || Lake & Trail Outdoor First Aid Kit, Item MJR-420; || Lake & Trail Outdoor First Aid Kit, Item MJR440; || First aid kits labeled DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544: || meijer First Aid Kit, Item MJR-130; || meijer First Aid Kit, Item MJR-442; || First Aid Kits labeled FIRST AID Exchange: || General Purpose Home First Aid Kit, Item 2800; || Auto First Aid Kit, Item 2825 || First Aid Kit labeled Distributed by Medicine Shoppe International St. Louis, MO: || All purpose First Aid Kit, Item FAO-132-MS || First Aid Kit labeled Mfg. by First Aid Only, Inc. Vancouver, WA Ready Solutions: || First Aid Kit, Item 90030 || First Aid Kit labeled NORTHERN Safety Co., Inc.: || First Aid Kit, Item FAO-442-NS || First Aid Kit labeled Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30060: || Grafco First Aid Kit, Item 1799-9133 and || First Aid Kit labeled -Provided by MOTURIS LTD- || Custom Kit, Item 9099
  • Manufacturer
    First Aid Only Inc

Manufacturer

First Aid Only Inc
  • Dirección del fabricante
    First Aid Only Inc, 11101 Ne 37th Cir, Vancouver WA 98682-7218
  • Source
    USFDA