AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-55...

FDA Device Recall #Z-2321-2012 — Class II — August 9, 2012

Recall Summary

Recall Number Z-2321-2012
Classification Class II — Moderate risk
Date Initiated August 9, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm AmeriWater Inc
Location Dayton, OH
Product Type Devices
Quantity 80 Units

Product Description

AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers.

Reason for Recall

The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses instead of 250 volt 15 amp fuses, that was installed in the water system. The incorrect fuse may result in excessive heat in the fuse holder eventually resulting in failure of the device to operate.

Distribution Pattern

Worldwide distribution: USA (nationwide) including states of: AL, AR, CO, CT, FL, GA, IL, IN, KS, MA, MD, MO, MS, NC, NY, OH, OK, SC, TN, TX and VA; and country of: Canada.

Lot / Code Information

Model Number MROS, Catalog #00MROS20, 00MROS21 & Model Number MRO1, Catalog #00MRO120, and 00MRO121; Model Number(s): MROS and MRO1; Serial #'s 31000 to 31079.

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.