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Recall Observatory FDA recall evidence

Drug product

K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue

D-0179-2017

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-0179-2017

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 # 80-0211 - 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

Distribution pattern: Nationwide, Australia & Switzerland

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility