Recall Z-2132-2016

Lifeline First Aid LLC · initiated May 16, 2016

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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

Codes / lots: 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

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: Other

Action taken

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.

Details

Recall number
Z-2132-2016
Initiated
May 16, 2016
Posted by FDA
July 6, 2016
Terminated
February 22, 2017
Product code
CBP – Valve, Non-Rebreathing
Quantity
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.
Recalling firm
Lifeline First Aid LLC, Wilsonville, OR

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2133-2016 Class II5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.Cadillac First Aid Kit is recalled because it contains the CPR Shield with One Way Valve and Barrier Filter… 05/16/2016Terminated