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Recall Observatory FDA recall evidence

Drug product

Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue

D-0176-2017

September 27, 2016

Class II

Product summary

Firm
North American Rescue LLC.
Event
Event 75415
Status
Terminated
Classification
Class II
Quantity
unknown
Official record key
drug-enforcement:D-0176-2017

Official wording

Reason: Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

Code information: 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

Distribution pattern: Nationwide, Australia & Switzerland

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility

Field note

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