Events

Rappel de Device Recall First Aid Only and First Aid Exchange

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-0854-2008
  • 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=66951
  • 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 Cabinets - 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 First Aid Only and First Aid Exchange
  • 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 Only brand cabinets (typically metal wall mount) containing ibuprofen tablets and a variety of other first aid supplies: || Item 249-0/FAO || Item 249-0/P || Item 249-RK/P || First Aid Exchange brand cabinet: || Item 1300-FAE-0103 || Item 1300-FAE-0108 and || Item 1300-PAT-0109
  • 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