CLASS II Device recall · Reported 6 May 2015 · FDA Enforcement Report
2008 Series Hemodialysis Machines: 2008K2 with the following product recalled
Fresenius Medical Care Holdings is recalling 2008 Series Hemodialysis Machines: 2008K2 with the following, distributed nationwide in the US. The recall was initiated on 20 Feb 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1552-2015
- FDA event ID
- 70574
- Recalling firm
- Fresenius Medical Care Holdings, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Feb 2015
- FDA classified
- 29 Apr 2015
- Reported
- 6 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Feb 2015 | Recall initiated by company | |
| 29 Apr 2015 | Classified by FDA | +68 days |
| 6 May 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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- 152000 0K0S152001- 154000 0K0S154001- 160000 0K0S160001- 162000 0K0S162001- 165353 0S154030 1K0S-1000 1K0S-1022 1K0S-1027 1K0S-1029 1K0S-1035 1K0S-1037 1K0S-1044- 1046 1K0S-1065 1K0S-1067 1K0S-1070 1K0S-1094 1K0S-1095 1K0S-1102 1K0S-1103 1K0S-1121 1K0S165354- 174103 2K0S174104 2K0S174105- 174111 2K0S174150- 182134 2K0S-5783 2K0S-5802 2K0S-6015 2K0S-6046 2K0S-6065 2K0S-6067 2K0S-6109 2K0S-6232 2K0S-6266 2K0S-9573 3K0S182135- 188639 4K0S188640- 192508 4K0S192542 4K0S192545 4K0S192550- 192553 4K0S192555 4K0S192566- 192569 4K0S192571 4K0S192572 4K0S192575- 192577 4K0S192579 4K0S192581 4K0S192584- 192586 4K0S192588 4K0S192593 4K0S192602 4K0S192603 4K0S192605 4K0S192675 4K0S192738- 192740 4K0S-N592 4K0S-Q302 4K0S-Q350 4K0S-Q362 4K0S-Q425 4K0S-Q467 4K0S-Q470 4K0S-Q502 5K0S-132B 5K0S-856B 5K0S-T230 5K0S-V420 5K0S-X901 5K0S-Y378 6K0S-029N 6K0S-151Q 6K0S-180Q 6K0S-205M 6K0S-239M 6K0S-255N 6K0S-315N 6K0S-331Q 6K0S-821G 6K0S-903R 6K0S-942S 7K0S103279 7K0S103983 7K0S104826 7K0S112150 7K0S112155 7K0S115550 8K0S118640 8K0S121287 8K0S122793 8K0S126296- 126305 8K0S126314- 126323 8K0S126573 8K0S128448 8K0S128506 8K0S129030- 129033 8K0S129211- 129321 8K0S129335 8K0S129337- 129339 8K0S129369 8K0S129431- 129435 8K0S129440 8K0S129447- 129490 8K0S129503- 129516 8K0S129893 8K0S130289 8K0S130296 8K0S130300 8K0S130304 8K0S130324 8K0S130345 8K0S130347 8K0S130546 8K0S130548 8K0S130552 8K0S130556 8K0S130559 8K0S130565 8K0S130567 8K0S130571 8K0S130574 8K0S130726 8K0S130751 8K0S130768 8K0S130771- 130773 8K0S130819 8K0S130951 8K0S131043 8K0S131046 8K0S131120 8K0S131133 8K0S131328 8K0S131330 8K0S131449- 132162 9K0S132163- 135000 9K0S135001- 149208 9KOS137160 OKOS149422
Where was it sold?
Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 70574This product is part of a recall event; the main page for the event is 2008 Series Hemodialysis Machines: 2008K with the following product recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 2008 Series Hemodialysis Machines: 2008K with the following product recalled | Fresenius Medical Care Holdings | Other | Nationwide | |
| CLASS II | 2008 Series Hemodialysis Machines: 2008T with the following product recalled | Fresenius Medical Care Holdings | Other | Nationwide | |
| CLASS II | 2008 Series Hemodialysis Machines: 2008Kathome recalled | Fresenius Medical Care Holdings | Other | Nationwide |
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