Z-1770-2022 Class II Ongoing
FDA device recall Z-1770-2022 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: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 28, 2022
- Initiation Date
- Jun 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product 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
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)200422(21)0CHS3987 (01)4251285200234(11)200526(21)0CHS4108 (01)4251285200234(11)210623(21)1CHS5372 (01)4251285200234(11)210707(21)1CHS5405 (01)4251285200234(11)190305(21)9CHS2881 (01)4251285200234(11)190529(21)9CHS3090 Serial Numbers: 0CHS3987 0CHS4108 1CHS5372 1CHS5405 9CHS2881 9CHS3090
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1770-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026