Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master ...
FDA Device Recall #Z-2714-2016 — Class II — August 2, 2016
Recall Summary
| Recall Number | Z-2714-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 2, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Best Sanitizers Inc |
| Location | Walton, KY |
| Product Type | Devices |
| Quantity | 3,023 cases USA; 666 cases shipped to Canada (OTC drug there) |
Product Description
Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of two liquids (1 acid & 1 buffer) banded together.
Reason for Recall
Certain lots of the acid solution in Acecide-C are degrading faster than normal.
Distribution Pattern
Distributed to one (1) account in the state of PA. Distributed to one (1) account in Canada
Lot / Code Information
Lot Numbers: 16012ACE EXP 01/17,16036ACE EXP 02/17, 16015ACE EXP 01/17, 16040ACE EXP 02/17, 16019ACE EXP 01/17, 16043ACE EXP 02/17, 16022ACE EXP 01/17, 16048ACE EXP 02/17, 16026ACE EXP 01/17, 16050ACE EXP 02/17, 16033ACE EXP 02/17. Lot Numbers 16015ACE EXP 01/17, 16036ACE EXP 02/17 were shipped to Olympus in Canada
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.