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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug

North American Rescue LLC.: Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

Agency Publication Date: December 8, 2016
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Affected Products

Product: Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue

Kit Part # 85-0889 - Kit Lot # 85-0889082416, 85-0889071816, 85-0889071916, 85-0889071416, 85-0889052316, 85-0889050416, 85-0889042016, 85-0889041416, 85-0889090616, 85-0889090716, 85-0889060216, 85-0889062216, 85-0889080116, 85-0889080816

Lot Numbers:
85-0889082416
Product: Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue

Kit Part # 80-0213 - Kit Lot # 80-0213080816W, 80-0213071316W, 80-0213041816W, 80-0213051716W, 80-0213050516W, 80-0213050916W, 80-0213081116W, 80-0213081716W, 80-0213082516W, 80-0213090216W, 80-0213090916W, 80-0213070716W, 80-0213080316W, 80-0213080116W, 80-0213072716W, 80-0213090916W; Kit Part # 80-0299 - Kit Lot # 80-0299080916W, 80-0299071116W, 80-0299060116W, 80-0299051916W, 80-0299081716W, 80-0299050316W, 80-0299051016W, 80-0299082216W; 80-0299082416W, 80-0299090616W, 80-0299090716W, 80-0299090716W, 80-0299080416W; Kit Part # 80-0298 - Kit Lot # 80-0298081116W, 80-0298060116W, 80-0298062316W, 80-0298090716W

Lot Numbers:
80-0213080816W
80-0299080916W
80-0298081116W
Product: Range Trauma Kit - Product Code 85-1274, North American Rescue

Kit Part # 85-1274 - Kit Lot # 85-1274072516W

Lot Numbers:
85-1274072516W
Product: Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue

Kit Part # 85-0742 Kit Lot # 85-0742071816; Kit Part # 85-0748 Kit Lot # 85-0746061016; Kit Part # 85-0745 - Kit Lot # 85-0745042516; Kit Part # 85-0639 - Kit Lot # 85-0639080516, 85-0639060116, 85-0639061016, 85-0639071416, 85-0639072116, 85-0639050316, 85-0639050416, 85-0639051316, 85-0639082216, 85-0639090116, 85-0639090716, 85-0639080116, 85-0639091316; Kit Part # 85-0744 - Kit Lot # 85-0744072516, 85-0744060916, 85-0744052516; Kit Part # 85-0741- Kit Lot # 85-0741071416

Lot Numbers:
85-0742071816
85-0746061016
85-0745042516
85-0639080516
85-0744072516
85-0741071416
Product: K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue

Kit Part # 80-0211 - Kit Lot # 80-0211070616, 80-0211051316, 80-0211041816, 80-0211030216, 80-0211072216, 80-0210070716, 80-0210050416W, 80-0210072216; Kit Part # 80-0304 - Kit Lot # 80-0304041916; Kit Part # 80-0209 - Kit Lot # 80-0209082216, 80-0209051816, 80-0209051616, 80-029050316, 80-0209041916, 80-0209060316; Kit Part # 80-210 Kit Lot # 80-021007076, 80-0210050416W, 80-0210072216; Kit Part # 80-0300 - Kit Lot # 80-0300081216, 80-0300050916, 80-0300050316, 80-0300041916, 80-0300082416; Kit Part #80-0301 - Kit Lot # 80-0301042916, 80-0301050316

Lot Numbers:
80-0211070616
80-0304041916
80-0209082216
80-021007076
80-0300081216
80-0301042916
Product: Amphibious Trauma Kit - Product Code 85-0639, North American Rescue

Kit Part # 85-0639 - Kit Lot # 85-0639080516, 85-0639060116, 85-0639061016, 85-0639071416, 85-0639072116, 85-0639050316, 85-0639050416, 85-0639051316, 85-0639082216, 85-0639090116, 85-0639091316

Lot Numbers:
85-0639080516
Product: Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue

Kit Part # 85-0835 - Kit Lot # 85-0835061016, 85-0835052416, 85-0835051116, 85-0835050216, 85-0835042916, 85-0835072616, 85-0835072016

Lot Numbers:
85-0835061016
Product: Aid Backpack Kit - Product Code 85-0917, North American Rescue

Kit Part # 85-0917 - Kit Lot # 85-0917041916

Lot Numbers:
85-0917041916
Product: USCG Boat Response Kit - Product Code 80-0353, North American Rescue

Kit Part # 80-0353 - Kit Lot # 80-0353051916

Lot Numbers:
80-0353051916

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 75415
Status: Resolved
Manufacturer: North American Rescue LLC.
Manufactured In: United States
Units Affected: 9 products (unknown; unknown; unknown; unknown; unknown; unknown; unknown; unknown; unknown)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.