FDAClass IIDecember 14, 2016

USCG Boat Response Kit recall: Sterility Concern

USCG Boat Response Kit - Product Code 80-0353, North American Rescue

Why was USCG Boat Response Kit recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Kit Part # 80-0353 - Kit Lot # 80-0353051916

Product
USCG Boat Response Kit - Product Code 80-0353, North American Rescue
Recalling firm
North American Rescue LLC.
Quantity
unknown
Distribution
Nationwide, Australia & Switzerland
Recall date
December 14, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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