Events

Recall of Device Recall General Motors brand

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
    74329
  • Event Risk Class
    Class 2
  • Event Number
    Z-2133-2016
  • Event Initiated Date
    2016-05-16
  • Event Date Posted
    2016-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147244
  • 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
    Valve, non-rebreathing - Product Code CBP
  • Reason
    Cadillac first aid kit is recalled because it contains the cpr shield with one way valve and barrier filter (mask) and this mask is cleared only for prescription use and is not cleared for over-the-counter (otc) use.
  • Action
    The firm sent the PRODUCT RECALL NOTICE- LIFELINE FIRST AID KITS WHICH INCLUDE CPR MASK letter, dated 5/11/2016, to their consignees. CPR shields will be replaced without charge and acceptable Lifeline First Aid kits will be re-worked and returned using our standard RGA process. In addition, the firm sent the PRODUCT RECALL NOTICE- CADILLAC FIRST AID KIT letter, dated May 31, 2016, to General Motors. General Motors will be sending out a dealership bulletin to inform their customers of this issue. Once confirmed, replacement masks will be sent to the requested dealerships and made available to be ordered (at no cost) as needed. Please complete and fax the attached Customer Response Form to Lifeline at (503)783-3721. Consignees with questions should call Lifeline First Aid, LLC at (503)783-3660.

Device

Device Recall General Motors brand
  • Model / Serial
    Exp Dates/Lot # Jan-16; 14181 Nov-16; 15077 Nov-16; 15097 Mar-17; 15278 Oct-17; 16068
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in AZ, CA, CO, FL, GA, IL, KY, MD, MN, MO, MT, NE, NJ, NY, OK, OR, PA, SC, TN, UT, VA, WA, WA, and WI. Also distributed in New Zealand.
  • Product Description
    5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.
  • Manufacturer
    Lifeline First Aid LLC

Manufacturer

Lifeline First Aid LLC
  • Manufacturer Address
    Lifeline First Aid LLC, 26200 SW 95th Ave Ste 302, Wilsonville OR 97070-8204
  • Manufacturer Parent Company (2017)
    Lifeline First Aid Llc
  • Source
    USFDA