The Recall Desk
HighFDA (Devices)·Z-2321-2012·Announced 2012-09-12

AmeriWater MRO Dialysis Systems Recalled Due to Incorrect Fuse Installation

AmeriWater Inc is recalling 80 MRO Dialysis RO+ Systems because incorrect fuses were installed, which may cause excessive heat and device failure.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for hemodialysis where a defect (incorrect fuse) poses a risk of device failure and excessive heat, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

AmeriWater Inc is recalling 80 units of the AmeriWater MRO Dialysis RO+ System, including models MROS and MRO1. These water treatment systems are intended for use in hemodialysis applications to pre-treat and purify potable water for making dialysate. The affected units were distributed nationwide in the United States and in Canada.

The recall was initiated after the firm was notified that a malfunction was caused by the installation of incorrect fuses. Specifically, 32-volt 15-amp fuses were installed instead of the required 250-volt 15-amp fuses. The source text states that this incorrect fuse installation may result in excessive heat in the fuse holder, which can eventually lead to the failure of the device to operate.

Affected units are identified by Model Numbers MROS and MRO1, Catalog Numbers 00MROS20, 00MROS21, 00MRO120, and 00MRO121, and Serial Numbers 31000 to 31079. Consumers and healthcare facilities should contact AmeriWater Inc at (800) 535-5585 or visit www.AMERIWATER.com for further instructions on how to address this issue.

The recalled product

Product
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
Manufacturer
AmeriWater Inc
Category
Medical Device — Water Treatment / Dialysis
Hazard
Affected units
80

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

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

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically:

Related recalls

Same hazard · device failure

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