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Recall Observatory FDA recall evidence

Drug product

Range Trauma Kit - Product Code 85-1274, North American Rescue

D-0177-2017

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-0177-2017

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

Distribution pattern: Nationwide, Australia & Switzerland

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility