Date Initiated by Firm: December 14, 2017
Create Date: 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) indicated 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