Z-1769-2022Class II

AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis...

Name: Z-1769-2022 AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2022-06-21
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2022-06-21 / Open, Classified

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of 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... on 2022-06-21. FDA classified it as Class II and gives the reason as "Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1769-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-21
Posted: 2022-09-19
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: 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
Product code: FIP Subsystem, Water Purification
Reason for recall: Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
FDA 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 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.
Quantity in commerce: 24 units
Distribution: US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV, NY, PA, TX.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1769-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1769-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-19
Z-1770-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-19

Product code FIP

K143617Class IIAquaC UNO HVivonic GmbH / cleared 2015-10-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)