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U.S. Department of Health and Human Services

Class 2 Device Recall General Motors brand

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  Class 2 Device Recall General Motors 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-2133-2016
Recall Event ID 74329
510(K)Number K083418  
Product Classification Valve, non-rebreathing - Product Code CBP
Product 5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.
Code Information Exp Dates/Lot # Jan-16; 14181 Nov-16; 15077 Nov-16; 15097 Mar-17; 15278 Oct-17; 16068 
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		 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.
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 2975 kits
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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