Fresenius 2008 Series Hemodialysis Machines: Models: 2008H — Class II medical device recall Z-0629-2014
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2014-01-15, distributed nationwide. 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and s
| Recall number | Z-0629-2014 |
|---|---|
| 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 | 2013-11-12 |
| Classified | 2014-01-06 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2019-03-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Model numbers | 2008H, 2008K, 2008K2, 2008T |
Product
Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate. The dialysate delivery machine is used for hemodialysis in hospital, dialysis centers, and at home. The 2008K, 20081(2 and 2008T hemodialysis machines are designed to perform hemodialysis in hospitals and dialysis clinics. They can be used for patients suffering chronic or acute renal failure. The 2008K, 2008K2 and 2008T are designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. The Fresenius 2008K~home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K~home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
Reason for recall
2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup
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-0629-2014. 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.