Key Takeaway

USCG Boat Response Kit - Product Code 80-0353, North American Rescue by North American Rescue LLC. was recalled on September 27, 2016. The hazard: Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

FDA Drug Class II Terminated

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

Recalled: September 27, 2016 ~unknown units affected D-0183-2017

Description

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

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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

Drugs

Company Information

North American Rescue LLC.

Greer, SC, United States

View all 9 recalls by North American Rescue LLC. →

Distribution

Nationwide, Australia & Switzerland

Related Recalls

FDA Drug Class II

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

September 27, 2016
FDA Drug Class II

Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue

September 27, 2016
FDA Drug Class II

Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue

September 27, 2016
FDA Drug Class II

Aid Backpack Kit - Product Code 85-0917, North American Rescue

September 27, 2016
FDA Drug Class II

Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue

September 27, 2016
FDA Drug Class II

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

September 27, 2016

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.