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
- Recall Initiated
- June 21, 2022
- Posted
- September 19, 2022
- Recall Number
- Z-1769-2022
- Quantity
- 24 units
- Firm Location
- Waltham, MA
Reason for Recall
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
Distribution
US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV, NY, PA, TX.
Lot / Code Info
UDI: (01)4251285200234(11)210628(21)1CHS5379 (01)4251285200234(11)160927(21)6CHS1270 (01)4251285200234(11)161109(21)6CHS1394 (01)4251285200234(11)161109(21)6CHS1435 (01)4251285200234(11)170131(21)7CHS1569 (01)4251285200234(11)170201(21)7CHS1583 (01)4251285200234(11)170213(21)7CHS1619 (01)4251285200234(11)170314(21)7CHS1641 (01)4251285200234(11)170519(21)7CHS1790 (01)4251285200234(11)170807(21)7CHS1953 (01)4251285200234(11)180326(21)8CHS2197 (01)4251285200234(11)181010(21)8CHS2608 (01)4251285200234(11)181102(21)8CHS2633 (01)4251285200234(11)181107(21)8CHS2644 Serial Numbers: 1CHS5379 6CHS1192 6CHS1194 6CHS1195 6CHS1196 6CHS1197 6CHS1198 6CHS1199 6CHS1200 6CHS1201 6CHS1233 6CHS1270 6CHS1394 6CHS1435 7CHS1569 7CHS1583 7CHS1619 7CHS1641 7CHS1790 7CHS1953 8CHS2197 8CHS2608 8CHS2633 8CHS2644
Root Cause
Under Investigation by firm
Action Taken
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.