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 | Terminated |
| Reason | 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump |
| Product | Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K |
| Quantity | 39 units |
| Distribution | USA (nationwide) and the country of Canada.* |
| Initiated | 2014-04-25 |
| Classified | 2014-05-13 |
| Terminated | 2021-05-18 |
| Recall number | Z-1619-2014 |
| 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-1619-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68042/
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