Events

Recall of first aid kit

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
    36566
  • Event Risk Class
    Class 2
  • Event Number
    Z-0147-2007
  • Event Initiated Date
    2006-08-17
  • Event Date Posted
    2006-11-02
  • 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=48922
  • 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 kit - Product Code LRR
  • Reason
    Kits contain acetaminophen tablets that were recalled due to being contaminated with mold.
  • Action
    The firm issued a letter dated August 17, 2006 to their customers advising of the recall and requesting product be removed from retail level and returned to the firm.

Device

first aid kit
  • Model / Serial
    Kit code C-0234, C-0244, C-0254, C-0264  Acetaminophen coded 03M847, expiration 12/06
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Kits were distributed nationwide to distributors, retailers and to one international distributor.
  • Product Description
    First Aid Kit, Nexcare brand, all purpose first aid kit containing acetaminophen and a variety of first aid supplies. Made in U.S.A. for 3M 3M Consumer Health Care St. Paul, MN 55144-1000
  • 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