Events

Recall of Device Recall LHB, First Aid Type I

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lighthouse For The Blind.

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
    64776
  • Event Risk Class
    Class 3
  • Event Number
    Z-1088-2013
  • Event Initiated Date
    2013-03-22
  • Event Date Posted
    2013-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117025
  • 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 with drug - Product Code LRR
  • Reason
    The product contains an iodine 10% ampule (10% povidone iodine swab) which is being recalled by the firm's distributor. the labeling of the iodine 10% ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. the antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili.
  • Action
    The firm sent "URGENT DEVICE RECALL" letters dated March 22, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 800-542-3697 for questions regarding this notice.

Device

Device Recall LHB, First Aid Type I
  • Model / Serial
    All kits shipped between 1/12010 through 3/4/2013.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including DC and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, MI, MD, MN, MO, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA and WY.
  • Product Description
    LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. || First Aid Kit.
  • Manufacturer
    Lighthouse For The Blind

Manufacturer

Lighthouse For The Blind
  • Manufacturer Address
    Lighthouse For The Blind, 10440 Trenton Ave, Olivette MO 63132-1223
  • Manufacturer Parent Company (2017)
    Lighthouse For The Blind
  • Source
    USFDA