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U.S. Department of Health and Human Services

Class 2 Device Recall AmeriWater MRO Dialysis RO System

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  Class 2 Device Recall AmeriWater MRO Dialysis RO System see related information
Date Initiated by Firm August 09, 2012
Date Posted September 06, 2012
Recall Status1 Terminated 3 on April 17, 2014
Recall Number Z-2321-2012
Recall Event ID 62891
510(K)Number K111740  
Product Classification Subsystem, water purification - Product Code FIP
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 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.
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.
Recalling Firm/
Manufacturer		 AmeriWater Inc
1303 Stanley Ave
Dayton OH 45404-1015
For Additional Information Contact Joeseph Haney
800-535-5585
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, AmeriWater, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 9, 2012, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the product subject to recall; remove affected devices from service until the correction is completed to prevent malfunction of the device during patient treatment; and complete and return the attached response form to AmeriWater within 30 days via fax to 937/461-1988 Attn: Quality Assurance. AmeriWater dealer will be contacting their customers to schedule replacement of the fuses. If you have any questions, contact your local AmeriWater dealer or AmeriWater customer service at 1-800-535-5585.
Quantity in Commerce 80 Units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FIP and Original Applicant = AMERIWATER
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