Z-1769-2022 Class II Ongoing
FDA device recall Z-1769-2022 was initiated by Fresenius Medical Care Holdings, Inc. on Jun 21, 2022 and is designated Class II. Reason for recall: Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured The recall status is ongoing. Affected quantity: 24 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 28, 2022
- Initiation Date
- Jun 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units
Product Description
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
Reason for Recall
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV, NY, PA, TX.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1769-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026