CLASS II Device recall · Reported 11 Apr 2018 · FDA Enforcement Report

2008 K2 Hemodialysis Machine recalled by Fresenius Medical Care Renal

Fresenius Medical Care Renal Therapies Group is recalling 2008 K2 Hemodialysis Machine, distributed in 16 states. The recall was initiated on 14 Dec 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 0K0S151801 UDI 00840861100866 190630,(+Serial Number) UDI 00840861100859 PLS 190610, (+Serial Number 1K0S169898 1K0S169954 1K0S170154 1K0S170234 1K0S171275 1K0S171286 1K0S171421 1K0S171436 2K0S176243 2K0S176244 2K0S176257 2K0S176264 2K0S176271 2K0S176273 2K0S176278 2K0S176280 2K0S176281 2K0S176283 2K0S176286 2K0S176443 2K0S176472 2K0S176633 4K0S188834 4K0S188841 4K0S188843 4K0S188987 4K0S189246 4K0S189293 4K0S189300 4K0S189353 4K0S189488 4K0S189797 4K0S189915 4K0S189939 4K0S190064 4K0S190067 4K0S190091 4K0S190111 4K0S190115 4K0S190119 4K0S190121 4K0S190126 4K0S190140 4K0S190141 4K0S190145 4K0S190146 4K0S190166 4K0S190173 4K0S190175 4K0S190183 4K0S190203 4K0S190212 4K0S190222 4K0S190226 4K0S191575 4K0S191910 5K0S193681 5K0S193682 5K0S193688 5K0S193689 5K0S193690 5K0S193696 5K0S193699 5K0S193701 5K0S193702 5K0S193707 5K0S193710 5K0S193711 5K0S193712 5K0S193713 5K0S193721 5K0S193732 5K0S193733 5K0S193734 5K0S193735 5K0S193736 5K0S193737 5K0S193740 5K0S193741 5K0S193747 5K0S193750 5K0S193753 5K0S193756 5K0S193757 5K0S193758 5K0S193761 5K0S193765 5K0S193769 5K0S193774 5K0S193776 5K0S193777 5K0S193778 5K0S193781 5K0S193783 5K0S193788 5K0S193789 5K0S193790 5K0S193794 5K0S193798 5K0S193799 5K0S193801 5K0S193808 5K0S193812 5K0S193820 5K0S193822 5K0S193823 5K0S193824 5K0S193830 5K0S193834 5K0S193835 5K0S193839 5K0S193842 5K0S193843 5K0S193851 5K0S193853 5K0S193854 5K0S193861 5K0S193864 5K0S193865 5K0S193866 5K0S193867 5K0S193872 5K0S193875 5K0S193877 5K0S193879 5K0S193883 5K0S193887 5K0S193889 5K0S193891 5K0S193892 5K0S193895 5K0S193898 5K0S193900 5K0S193901 5K0S193902 5K0S193903 5K0S193904 5K0S193905 5K0S193909 5K0S193910 5K0S193912 5K0S193914 5K0S193916 5K0S193917 5K0S193918 5K0S193919 5K0S193920 5K0S193921 5K0S193922 5K0S193924 5K0S193925 5K0S193927 5K0S193928 5K0S193929 5K0S193930 5K0S193932 5K0S193935 5K0S193937 5K0S193940 5K0S193944 5K0S193946 5K0S193948 5K0S193957 5K0S193963 5K0S193965 5K0S193966 5K0S193975 5K0S193976 5K0S193981 5K0S193983 5K0S193986 5K0S193987 5K0S193988 5K0S193991 5K0S193992 5K0S193995 5K0S193998 5K0S193999 5K0S194004 5K0S194007 5K0S194008 5K0S194010 5K0S194016 5K0S194021 5K0S194028 5K0S194032 5K0S194033 5K0S194035 5K0S194041 5K0S194045 5K0S194046 5K0S194051 5K0S194059 5K0S194065 5K0S194067 5K0S194068 5K0S194071 5K0S194072 5K0S194074 5K0S194075 5K0S194077 5K0S194079 5K0S194080 5K0S194098 5K0S194099 5K0S194101 5K0S194102 5K0S194104 5K0S194106 5K0S194107 5K0S194109 5K0S194111 5K0S194112 5K0S194113 5K0S194118 5K0S194122 5K0S194125 5K0S194126 5K0S194127 5K0S194130 5K0S194132 5K0S194133 5K0S194134 5K0S194136 5K0S194139 5K0S194141 7K0S-103983 8K0S126369ZZNOTUSE 8K0S131332 8K0S132008 8K0S132012 9K0S133294 9K0S139189 9K0S141552

Quantity recalled127

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-1278-2018
FDA event ID: 79478
Recalling firm: Fresenius Medical Care Renal Therapies Group, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 14 Dec 2017
FDA classified: 30 Mar 2018
Reported: 11 Apr 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Medical Software

Timeline

14 Dec 2017	Recall initiated by company
30 Mar 2018	Classified by FDA	+106 days
11 Apr 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.

Where it was distributed

US Distribution to the states of: AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, and TX.

Arkansas California Colorado Florida Georgia Illinois Massachusetts Maryland Minnesota North Carolina New York Ohio Pennsylvania South Carolina Tennessee Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Numbers: 0K0S151801 UDI 00840861100866 190630,(+Serial Number) UDI 00840861100859 PLS 190610, (+Serial Number 1K0S169898 1K0S169954 1K0S170154 1K0S170234 1K0S171275 1K0S171286 1K0S171421 1K0S171436 2K0S176243 2K0S176244 2K0S176257 2K0S176264 2K0S176271 2K0S176273 2K0S176278 2K0S176280 2K0S176281 2K0S176283 2K0S176286 2K0S176443 2K0S176472 2K0S176633 4K0S188834 4K0S188841 4K0S188843 4K0S188987 4K0S189246 4K0S189293 4K0S189300 4K0S189353 4K0S189488 4K0S189797 4K0S189915 4K0S189939 4K0S190064 4K0S190067 4K0S190091 4K0S190111 4K0S190115 4K0S190119 4K0S190121 4K0S190126 4K0S190140 4K0S190141 4K0S190145 4K0S190146 4K0S190166 4K0S190173 4K0S190175 4K0S190183 4K0S190203 4K0S190212 4K0S190222 4K0S190226 4K0S191575 4K0S191910 5K0S193681 5K0S193682 5K0S193688 5K0S193689 5K0S193690 5K0S193696 5K0S193699 5K0S193701 5K0S193702 5K0S193707 5K0S193710 5K0S193711 5K0S193712 5K0S193713 5K0S193721 5K0S193732 5K0S193733 5K0S193734 5K0S193735 5K0S193736 5K0S193737 5K0S193740 5K0S193741 5K0S193747 5K0S193750 5K0S193753 5K0S193756 5K0S193757 5K0S193758 5K0S193761 5K0S193765 5K0S193769 5K0S193774 5K0S193776 5K0S193777 5K0S193778 5K0S193781 5K0S193783 5K0S193788 5K0S193789 5K0S193790 5K0S193794 5K0S193798 5K0S193799 5K0S193801 5K0S193808 5K0S193812 5K0S193820 5K0S193822 5K0S193823 5K0S193824 5K0S193830 5K0S193834 5K0S193835 5K0S193839 5K0S193842 5K0S193843 5K0S193851 5K0S193853 5K0S193854 5K0S193861 5K0S193864 5K0S193865 5K0S193866 5K0S193867 5K0S193872 5K0S193875 5K0S193877 5K0S193879 5K0S193883 5K0S193887 5K0S193889 5K0S193891 5K0S193892 5K0S193895 5K0S193898 5K0S193900 5K0S193901 5K0S193902 5K0S193903 5K0S193904 5K0S193905 5K0S193909 5K0S193910 5K0S193912 5K0S193914 5K0S193916 5K0S193917 5K0S193918 5K0S193919 5K0S193920 5K0S193921 5K0S193922 5K0S193924 5K0S193925 5K0S193927 5K0S193928 5K0S193929 5K0S193930 5K0S193932 5K0S193935 5K0S193937 5K0S193940 5K0S193944 5K0S193946 5K0S193948 5K0S193957 5K0S193963 5K0S193965 5K0S193966 5K0S193975 5K0S193976 5K0S193981 5K0S193983 5K0S193986 5K0S193987 5K0S193988 5K0S193991 5K0S193992 5K0S193995 5K0S193998 5K0S193999 5K0S194004 5K0S194007 5K0S194008 5K0S194010 5K0S194016 5K0S194021 5K0S194028 5K0S194032 5K0S194033 5K0S194035 5K0S194041 5K0S194045 5K0S194046 5K0S194051 5K0S194059 5K0S194065 5K0S194067 5K0S194068 5K0S194071 5K0S194072 5K0S194074 5K0S194075 5K0S194077 5K0S194079 5K0S194080 5K0S194098 5K0S194099 5K0S194101 5K0S194102 5K0S194104 5K0S194106 5K0S194107 5K0S194109 5K0S194111 5K0S194112 5K0S194113 5K0S194118 5K0S194122 5K0S194125 5K0S194126 5K0S194127 5K0S194130 5K0S194132 5K0S194133 5K0S194134 5K0S194136 5K0S194139 5K0S194141 7K0S-103983 8K0S126369ZZNOTUSE 8K0S131332 8K0S132008 8K0S132012 9K0S133294 9K0S139189 9K0S141552

Where was it sold?

US Distribution to the states of: AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, and TX.

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.

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