Class 2 Device Recall General Motors brand

• Date Initiated by Firm: May 16, 2016
• Date Posted: July 06, 2016
• Recall Status: Terminated 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
• FEI Number: 3002714597
• 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: 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