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Recall Observatory FDA recall evidence

Drug product

Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue

D-0178-2017

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-0178-2017

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 # 85-0742 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

Distribution pattern: Nationwide, Australia & Switzerland

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility