Events

Recall of Device Recall Highlands First Aid Kit

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

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
    60041
  • Event Risk Class
    Class 2
  • Event Number
    Z-0121-2012
  • Event Initiated Date
    2011-07-07
  • Event Date Posted
    2011-10-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104290
  • 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 first aid kits are recalled because the kits contain iodine prep pad single use wipes which were recalled by triad.
  • Action
    Lifeline First Aid, LLC sent a " PRODUCT RECALL NOTICE-LIFELINE FIRST AID KITS WHICH INCLUDE H & P [TRIAD] PVP IODINE WIPES" letter dated July 7, 2011 to all affected customers. The letter states that Lifeline First Aid, LLC has become aware of a recall of Povidone Iodine Wipes manufactured by H&P; Industries Inc. (TRIAD GROUP) and marketed under various brand names, including Triad and Swift. The recall of the Povidone Iodine Wipe is due to potential microbial contamination of the product. The letter instructs customers to collect and quarantine all affected products and to complete and return an attached Customer Response Form via fax to (503) 783-3721. Affected products will be replaced without charge and acceptable Lifeline first aid kits will be re-worked and returned using Lifeline's standard RGA process. Customers may call Lifeline customer service at 1 (877) 377-8243 for further instructions.

Device

Device Recall Highlands First Aid Kit
  • Model / Serial
    no codes.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Highlands First Aid Kit, Part Number 4116, UPC 0-91966-04116-9, contains 65 Pieces. || The kit is labeled in parts: "***HIGHLANDS FIRST AID KIT***MODEL 4166*** || 1 IODINE PREP PADS***Lifeline First Aid, LLC***Wilsonville, OR 97070, USA***www.lifelinefirstaid.com***". || First aid kit.
  • Manufacturer
    Lifeline First Aid LLC

Manufacturer

Lifeline First Aid LLC
  • Manufacturer Address
    Lifeline First Aid LLC, 26200 SW 95th Ave Ste 301, Wilsonville OR 97070-8204
  • Source
    USFDA