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U.S. Department of Health and Human Services

Class 2 Device Recall Lifeline Brand

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  Class 2 Device Recall Lifeline Brand see related information
Date Initiated by Firm May 16, 2016
Date Posted July 06, 2016
Recall Status1 Terminated 3 on February 22, 2017
Recall Number Z-2132-2016
Recall Event ID 74329
510(K)Number K083418  
Product Classification Valve, non-rebreathing - Product Code CBP
Product 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
Code Information 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 
Recalling Firm/
Manufacturer		 Lifeline First Aid LLC
26200 SW 95th Ave Ste 302
Wilsonville OR 97070-8204
For Additional Information Contact Patti Douglas
503-783-3660
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 3572 units of item #4042; 29,088 units of item #4043; 1,248 units of item #4037
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBP and Original Applicant = FIRSTAR HEALTHCARE CO., LTD.
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