Z-1947-2026Class I

AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty...

Name: Z-1947-2026 AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty...
Creator: North American Rescue LLC.
Published: 2026-03-27
License: https://open.fda.gov/license/

North American Rescue LLC. / initiated 2026-03-27 / Open, Classified / root cause: design

FDA source

North American Rescue LLC. began a recall of AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level... on 2026-03-27. FDA classified it as Class I and gives the reason as "Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1947-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-03-27
Posted: 2026-04-29
Recalling firm: North American Rescue LLC.
Product: AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indications, is maintained for each device, which may be used independently and at different times. These specific kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that were recalled as part of RES 98317 with (510(k): K140100).
Product code: LRR First Aid Kit With Drug
Reason for recall: Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in appropriate treatment. This is a downstream recall of Trividia Health Class I, Recall Event ID 98317.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 3/27/2026, correction notices were emailed to customers asking them to take the following actions: For Health Care Professions: Notify your providers and patients who use the products. You may use the customer notice on page 5. For Multiple Patient Facilities: Please post the notice provided on page 6 in areas where the Products are stored within your facility to notify personnel of this labeling correction. For People with Diabetes: Follow the updated E-5 error code instructions in the notice on page 5. This correction should be carried out to the user level. If you have further distributed this product, notify them of this correction. Your notification may be enhanced by including this correction notification letter. Customers with questions can contact Trividia Health Customer Care at 1-888-835-2723, Monday-Friday 8AM-8PM EST (excluding holidays) or email. For links to the updated Owner's Booklets and help resources visit www.trividiahealth.com [email protected] The notice provides email www.NARercue.com
Quantity in commerce: 21
Distribution: US: CA, WA
Product codes and lots: Kit REF/UDI-DI/Lot: 85-4661/00842209132089/85-4661122024; 85-4742/00842209133536/85-4742123024. Meter: UDI-DI: 20612479197217, all lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1947-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1947-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-29

Product code LRR

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)