Events

Recall of Device Recall First Aid Only and First Aid Exchange

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by First Aid Only Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    46198
  • Event Risk Class
    Class 3
  • Event Number
    Z-0854-2008
  • Event Initiated Date
    2007-12-10
  • Event Date Posted
    2008-02-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66951
  • Notes / Alerts
    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.
  • Extra notes in the data
    First Aid Cabinets - Product Code LRR
  • Reason
    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
  • Model / 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.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Worldwide: USA and to one distributor in Dubai, United Arab Emirates.
  • Product Description
    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
  • Manufacturer Address
    First Aid Only Inc, 11101 Ne 37th Cir, Vancouver WA 98682-7218
  • Source
    USFDA