Revision K Actuator Test Boards sold as replacement parts for use… — Class II medical device recall Z-1619-2014
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2014-05-21, distributed nationwide. 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultra
| Recall number | Z-1619-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2014-04-25 |
| Classified | 2014-05-13 |
| Reported by FDA | 2014-05-21 |
| Terminated | 2021-05-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 39 units |
| Reason classes | device malfunction |
| Model numbers | 190713 |
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
Reason for recall
2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1619-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.