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CriticalRecall #Z-1947-2026Medical Device

North American Rescue LLC. Recalls AIDBAGs are first aid kits of convenience composed of.

North American Rescue LLC. · Class I — Most Serious

Hospital operating room medical equipment — representative photo for FDA medical device recall
A hospital operating room with medical equipment (representative file photo). Specific recalled device: see recall details below. Photo: FDA / Public Domain.

Product Description

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).

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.

FDA Classification

Class I — Most Serious

A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Distribution

US: CA, WA

Remedy

Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.

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