Events

Rappel de Device Recall Distributed under various trade names

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par First Aid Only Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    46198
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0853-2008
  • Date de mise en oeuvre de l'événement
    2007-12-10
  • Date de publication de l'événement
    2008-02-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66950
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    First Aid Kits - Product Code LRR
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    Not Classified
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide: USA and to one distributor in Dubai, United Arab Emirates.
  • Description du dispositif
    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
  • Adresse du fabricant
    First Aid Only Inc, 11101 Ne 37th Cir, Vancouver WA 98682-7218
  • Source
    USFDA