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U.S. Department of Health and Human Services

Class 2 Device Recall 2008 Series Hemodialysis Machine

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  Class 2 Device Recall 2008 Series Hemodialysis Machine see related information
Date Initiated by Firm December 14, 2017
Date Posted March 20, 2018
Recall Status1 Open3, Classified
Recall Number Z-1278-2018
Recall Event ID 79478
510(K)Number K153449  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product 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.
Code Information 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 
Recalling Firm/
Manufacturer
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact Fresenius Technical Service
800-227-2572
Manufacturer 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.
FDA Determined
Cause 2
Device Design
Action The recall notification instructs the user to the UF Goal with values less than 200ml when in Service Mode and to monitor and set the UF Rate to the desired setting after starting the SLED treatment. The consignee is advised that a software update is forthcoming to correct the issue. For further questions, please call (800) 227-2572.
Quantity in Commerce 127
Distribution US Distribution to the states of: AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, and TX.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
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