Recall Z-1769-2022 ยท FIP Subsystem, Water Purification
Fresenius Medical Care Holdings, Inc.
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US
| Date | Sep 19, 2022 (initiated Jun 21, 2022) |
| Status | Open, Classified |
| Reason | Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured |
| Root cause | Under Investigation by firm |
| Action | Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) issued Urgent Medical Deice Correction letter (FA-2022-20-C) on 06/21/22 via First Class Mail. Letter states reason for recall, health risk and action to take: A Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) Water Systems Service Specialist will be contacting you to schedule a correction of your portable Water Treatment system. Only a Certified AquaC UNO H System Technician or FMCRTG Water Systems Service Specialist may perform this service. If choosing to correct via your own Certified AquaC UNO H System Technician, you w |
| Quantity | 24 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV, NY, PA, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143617 | AquaC UNO H Vivonic GmbH, Oct 19, 2015 |