AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US
Recall
- Recall Number
- Z-1770-2022
- Event Number
- 90757
- Firm
- Fresenius Medical Care Holdings, Inc.
- FEI Number
- 3001451489
- Product Code
- FIP
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- June 21, 2022
- Posted
- September 19, 2022
- Address
- 920 Winter St, Bld 950, Waltham, MA, 02451-1521
Description
AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
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 will need to contact FMCRTG prior to performing the correction. FMCRTG will provide the necessary instruction via a Change Notification. For questions or concerns, please contact FMCRTG Technical Support Services at 888-553-1109.
US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV, NY, PA, TX.
6 units