CLASS II Device recall · Reported 13 Jul 2016 · FDA Enforcement Report

5195GM, Cadillac First Aid Kit, #23459698, brand General Motors recalled

Lifeline First Aid is recalling 5195GM, Cadillac First Aid Kit, #23459698, brand General Motors, distributed in 23 states. The recall was initiated on 16 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesExp Dates/Lot # Jan-16; 14181 Nov-16; 15077 Nov-16; 15097 Mar-17; 15278 Oct-17; 16068

Quantity recalled2975 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2133-2016
FDA event ID: 74329
Recalling firm: Lifeline First Aid, Wilsonville, OR
Classification: Class II
Status: Terminated
Recall initiated: 16 May 2016
FDA classified: 6 Jul 2016
Reported: 13 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 May 2016	Recall initiated by company
6 Jul 2016	Classified by FDA	+51 days
13 Jul 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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.

Arizona California Colorado Florida Georgia Illinois Kentucky Maryland Minnesota Missouri Montana Nebraska New Jersey New York Oklahoma Oregon Pennsylvania South Carolina Tennessee Utah

Questions about this recall

Is 5195GM, Cadillac First Aid Kit, #23459698, brand General Motors recalled?

Yes. Lifeline First Aid recalled 5195GM, Cadillac First Aid Kit, #23459698, brand General Motors on 16 May 2016. The recall is Class II and its status is Terminated. Recall number Z-2133-2016.

Why was it recalled?

Which lots are affected?

Exp Dates/Lot # Jan-16; 14181 Nov-16; 15077 Nov-16; 15097 Mar-17; 15278 Oct-17; 16068

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Lifeline First Aid

All 2

Reported	Class	Recall	Company	Reason	Where
13 Jul 2016Device	CLASS II	Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve recalled	Lifeline First Aid	Other	23 states

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide