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Recall Observatory FDA recall evidence

Drug product

Amphibious Trauma Kit - Product Code 85-0639, North American Rescue

D-0180-2017

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-0180-2017

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

Distribution pattern: Nationwide, Australia & Switzerland

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility