Events

Recall of Device Recall Lifeline 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-2132-2016
  • 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=147206
  • 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
    First aid kits or rescue kits are recalled because they 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 Lifeline Brand
  • Model / Serial
    item #4042 and item #4043 have the expiration date: 11/30/2017.  Item #4037 has the following lots and expiration dates: Lot # Expiration Date 101483; 3/15 101546; 6/15 101682; 7/15 101804; 1/16 101812; 1/16 102032; 5/16 102109; 5/16 102098; 5/17 102130; 5/16 102296; 10/16 102317; 10/16 102295; 10/16 102372; 1/17 102638; 1/17 102694; 8/17
  • 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
    Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. || Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline. || UPC Red color kit: 845174005464; || UPC Lime color kit: 845174005594; || UPC Purple color: 845174005600; || UPC of master case of 6 845174005471 (2 each color) || Item # 4037, Outfitter First Aid Kit, CPR shield with one way valve & barrier filter, brand Lifeline, UPC 845174003453
  • 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