2008 Series Hemodialysis Machines: 2008Kathome — Class II medical device recall Z-1549-2015
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-1549-2015 |
|---|---|
| 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 | 014Q, 015R, 019R, 023, 027M, 031Q, 051, 053M, 056, 063N, 078, 0K0S151413, 11M, 120, 121, 138, 168D, 185C, 195E, 1K0S167702-7721, 1K0S169224-244, 1K0S170300-311, 1K0S171475-499, 1K0S171807-849, 1K0S172042-061 and 335 more |
Product
2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX 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-1549-2015. 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.