2008 Series Hemodialysis Machines: 2008K with the following product… — Class II medical device recall Z-1551-2015
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2015-05-06, distributed nationwide. The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l
| Recall number | Z-1551-2015 |
|---|---|
| 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 | 2015-02-20 |
| Classified | 2015-04-29 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2021-05-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Serial numbers | 0015, 0028, 0032, 0036, 0040, 077, 0999, 0K0S-0009, 0K0S-0011, 0K0S-0018, 0K0S-0019, 0K0S-0021, 0K0S-0030, 0K0S-0034, 0K0S-0038, 0K0S-0042, 0K0S-0044, 0K0S-0080, 0K0S-0280, 0K0S-0287, 0K0S-0480, 0K0S-0554, 0K0S-0679, 0K0S-0886, 0K0S-0902 and 136 more |
Product
2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC and Diasafe Plus - Spanish; 190302 2008K System w/ OLC and Short Cab; 190306 2008K System w/ Short Cabinet; 190373 2008K System w/ Short Cabinet; 190305 2008K System w/o Diasafe; 190301 2008K System w/o HP; 190372 2008K System w/o HP; 190303 2008K System w/o OLC and Diasafe; 190304 2008K System w/o OLC and Diasafe and HP; 190452 2008K System w/o OLC and w/ Diasafe Plus; 190303 2008K W/O OLC and DIASAFE W/ HEPARIN PUMP; 190304 2008K W/O OLC and DIASAFE W/O HEPARIN PUMP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
Reason for recall
The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.
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-1551-2015. 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.