Z-2133-2016Class II

5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC

Name: Z-2133-2016 5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC
Creator: Lifeline First Aid LLC
Published: 2016-05-16
License: https://open.fda.gov/license/

Lifeline First Aid LLC / initiated 2016-05-16 / Terminated

FDA source

Lifeline First Aid LLC began a recall of 5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC on 2016-05-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2133-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-16
Posted: 2016-07-06
Terminated: 2017-02-22
Recalling firm: Lifeline First Aid LLC
Product: 5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.
Product code: CBP Valve, Non-Rebreathing
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 root 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.
Product codes and lots: Exp Dates/Lot # Jan-16; 14181 Nov-16; 15077 Nov-16; 15097 Mar-17; 15278 Oct-17; 16068

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2133-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2132-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-06
Z-2133-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-06

Product code CBP

K083418Class IICPR MaskFirstar Healthcare Co., Ltd. / cleared 2010-07-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)