2008 Series Hemodialysis Machines: 2008K2 with the following product… — Class II medical device recall Z-1552-2015
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-1552-2015 |
|---|---|
| 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 | 0K0S-0678, 0K0S-0885, 0K0S-0901, 0K0S-0917, 0K0S-0922, 0K0S-0927, 0K0S-0935, 0K0S-0943, 0K0S-0959, 0K0S-0960, 0K0S-0963, 0K0S-0992, 0K0S149209-149999, 0K0S150000, 0K0S152001, 0K0S154001, 0K0S160001, 0K0S162001, 0S154030, 1046, 126305, 126323, 129033, 129321, 129339 and 153 more |
Product
2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 190618 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; 190610 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; 190630 2008K2 MACHINE, SHORT CAB, OLC/DP, HP; 190628 2008K2 OLC ONLY WITH 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-1552-2015. 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.