RegWardenFDA facility compliance records
Recall

Class I — North American Rescue LLC.

Recalling firmNORTH AMERICAN RESCUE, LLC.
Registered facilityNORTH AMERICAN RESCUE, LLC. (the firm's only registered facility)
ClassificationClass I
StatusOngoing
ReasonKits 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.
ProductAIDBAGs 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).
Quantity21
DistributionUS: CA, WA
Initiated2026-03-27
Classified2026-04-29
Recall numberZ-1947-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class I recall — North American Rescue LLC. (Z-1947-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98697/

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