Class II — Fresenius Medical Care Holdings, Inc.
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured |
| 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 |
| Quantity | 24 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV, NY, PA, TX. |
| Initiated | 2022-06-21 |
| Classified | 2022-09-19 |
| Recall number | Z-1769-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Fresenius Medical Care Holdings, Inc. (Z-1769-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90757/
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