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

FDA Drug Recall #D-0175-2017 — Class II — September 27, 2016

Recall Summary

Recall Number D-0175-2017
Classification Class II — Moderate risk
Date Initiated September 27, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm North American Rescue LLC.
Location Greer, SC
Product Type Drugs
Quantity unknown

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide, Australia & Switzerland

Lot / Code Information

Kit Part # 85-0889 - Kit Lot # 85-0889082416, 85-0889071816, 85-0889071916, 85-0889071416, 85-0889052316, 85-0889050416, 85-0889042016, 85-0889041416, 85-0889090616, 85-0889090716, 85-0889060216, 85-0889062216, 85-0889080116, 85-0889080816

Other Recalls from North American Rescue LLC.

Recall # Classification Product Date
D-0178-2017 Class II Advance Trauma Kit - Product Code 85-0742, 85-0... Sep 27, 2016
D-0176-2017 Class II Range Trauma Kit ORG - Product Code 80-0213, 80... Sep 27, 2016
D-0183-2017 Class II USCG Boat Response Kit - Product Code 80-0353, ... Sep 27, 2016
D-0182-2017 Class II Aid Backpack Kit - Product Code 85-0917, North ... Sep 27, 2016
D-0181-2017 Class II Mini Resupply Trauma Kit - Product Code 85-0835... Sep 27, 2016

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.