• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall KIT, AIDBAG SMALL CRISIS 24 (REF: 854661) KIT, AIDBAG 1 V1.0 SEATTLE PD (REF: 854742).

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall KIT, AIDBAG SMALL CRISIS 24 (REF: 854661) KIT, AIDBAG 1 V1.0 SEATTLE PD (REF: 854742).see related information
Date Initiated by FirmMarch 27, 2026
Date PostedApril 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1947-2026
Recall Event ID 98697
Product Classification First Aid Kit with drug - Product Code LRR
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).
Code Information Kit REF/UDI-DI/Lot: 85-4661/00842209132089/85-4661122024; 85-4742/00842209133536/85-4742123024. Meter: UDI-DI: 20612479197217, all lots.
FEI Number 3005034064
Recalling Firm/
Manufacturer
North American Rescue LLC.
35 Tedwall Ct
Greer SC 29650-4791
For Additional Information Contact
864-675-9800
Manufacturer 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 Determined
Cause 2
Component design/selection
ActionOn 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 trividia0126CC@trividiahealth.com The notice provides email www.NARercue.com
Quantity in Commerce21
DistributionUS: CA, WA
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-