FDA Device recall Z-1549-2015
2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX
- FDA Device
- Class II
- terminated
- Published 2015-05-06
On 2015-05-06 the FDA classified a Class II recall of 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX by Fresenius Medical Care Holdings, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1549-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-20 |
| Published | 2015-05-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial numbers: 0K0S151413 1K0S167702-7721 1K0S169224-244 1K0S170300-311 1K0S171475-499 1K0S171807-849 1K0S172042…Serial numbers: 0K0S151413 1K0S167702-7721 1K0S169224-244 1K0S170300-311 1K0S171475-499 1K0S171807-849 1K0S172042-061 1K0S172179-199 1K0S172200-205 1K0S172263-266 2K0S174112-149 2K0S174228-246 2K0S175602-628 2K0S179477-501 2K0S180512 2K0S180513 2K0S180516-533 2K0S180542 2K0S180543 2K0S180546 2K0S180628 2K0S180629 2K0S181311-332 2K0S181338-340 2K0S181343-347 2K0S181705-719 3K0S182625-659 3K0S183305-324 3K0S183906-920 3K0S183971-980 3K0S184849-912 3K0S185281-284 3K0S185307-311 3K0S185716-745 3K0S185974-989 3K0S185991-998 3K0S186031-045 3K0S186933-962 3K0S186989-7002 4K0S190280 4K0S190306- 4K0S190307 4K0S190309 4K0S190313 4K0S190319 4K0S190509-543 4K0S190829-854 4K0S191122-141 4K0S191229-234 4K0S191511-513 4K0S191569-572 4K0S191578- 588 4K0S192226-245 4K0S192512 4K0S192514-517 4K0S192520 4K0S192522-524 4K0S192526 4K0S192528 4K0S192529 4K0S192533 4K0S192536 4K0S192538 4K0S192540 4K0S192729 4K0S192735 4K0S-J232 4K0S-J943-J94 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1549-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.