Drug recall
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA recall event 90527 · Class II · Fresenius Medical Care Holdings, Inc.
Key facts
| Event ID | 90527 |
|---|---|
| Recall numbers | Z-1463-2022, Z-1464-2022 |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Product type | Devices |
| Products | AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US, AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Jun 16, 2022 |
| Report date | Aug 3, 2022 |
| City | Waltham |
| State | MA |
| Country | United States |
| FEI number | 3001451489 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: