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 ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock |
| Product | AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US |
| Quantity | 318 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2022-06-16 |
| Classified | 2022-07-25 |
| Recall number | Z-1464-2022 |
| 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-1464-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90527/
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