Recall Z-2321-2012 ยท FIP Subsystem, Water Purification
AmeriWater Inc
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.) standar
| Date | Sep 6, 2012 (initiated Aug 9, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111740 | AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION Ameriwater, Oct 5, 2011 |