Events

Recall of Device Recall Distributed under various trade names

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-0853-2008
  • 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=66950
  • 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 Kits - 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 Distributed under various trade names
  • 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 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
  • Manufacturer Address
    First Aid Only Inc, 11101 Ne 37th Cir, Vancouver WA 98682-7218
  • Source
    USFDA