Class 2 Device Recall Blood Pump Rotor Part for 2008 Series Hemodialysis Machines

• Date Initiated by Firm: June 03, 2024
• Date Posted: July 11, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2343-2024
• Recall Event ID: 94775
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
• Code Information: Model Number: 190395; UDI/DI: 00840861100958; Serial Number: 6K0S-985P, 7K0S107747, 6K0S-021M, 7K0S103530, 6K0S-780R, 6K0S-192E, 6K0S-217E, 7K0S102986, 7K0S110138, 7K0S110142, 7K0S106422, 4K0S-P981, 4K0S-N154, 4K0S-N157, 4K0S-Q697, 5K0S-V190, 5K0S-V199, 6K0S-012R, 4K0S-M705, 4K0S-M708, 4K0S-N842, 4K0S-N843, 4K0S-N846, 4K0S-N850, 4K0S-N913, 4K0S-P289, 4K0S-P290, 4K0S-P298, 4K0S-P299, 4K0S-R079, 4K0S-R106, 4K0S-R114, 4K0S-R082, 4K0S-R136, 4K0S-S707, 4K0S-S708, 4K0S-S716, 6K0S-320H, 6K0S-325H, 6K0S-332H, 4K0S-S713, 5K0S-309C, 4K0S-M703, 4K0S-N847, 4K0S-R080, 4K0S-L722, 4K0S-N152, 4K0S-N155, 4K0S-N159, 4K0S-P291, 4K0S-P294, 4K0S-P295, 4K0S-Q694, 4K0S-Q688, 4K0S-R107, 4K0S-R081, 5K0S-T891, 4K0S-R135, 7K0S106375, 5K0S-168D, 5K0S-Z661, 5K0S-Z668, 4K0S-S711, 5K0S-306C, 5K0S-159D, 5K0S-881D, 6K0S-491J, 6K0S-501F, 6K0S-435N, 7K0S108256, 6K0S-746N, 5K0S-311C, 6K0S-508F, 6K0S-016M, 5K0S-305C, 6K0S-532F, 6K0S-318H, 6K0S-722R, 5K0S-Y002, 6K0S-481K, 6K0S-488K, 6K0S-669L, 4K0S-Q643, 5K0S-Y003, 4K0S-M704, 4K0S-M707, 4K0S-N849, 4K0S-P288, 4K0S-Q641, 4K0S-Q689, 4K0S-Q690, 4K0S-Q691, 4K0S-R109, 4K0S-R113, 4K0S-R134, 4K0S-R137, 4K0S-S704, 5K0S-T897, 5K0S-T898, 5K0S-V200, 5K0S-V201, 5K0S-X989, 5K0S-883D, 6K0S-468G, 6K0S-847G, 6K0S-848G, 6K0S-092L, 6K0S-322L, 6K0S-673L, 6K0S-992P, 6K0S-998P, 4K0S-M706, 4K0S-R083, 4K0S-S712, 4K0S-S722, 5K0S-V191, 5K0S-V204, 5K0S-X987, 5K0S-X990, 5K0S-Z667, 5K0S-466B, 6K0S-219E, 6K0S-482J, 6K0S-835N, 6K0S-778R, 7K0S100621, 7K0S102665, 7K0S103781, 4K0S-S715, 5K0S-V202, 5K0S-885D, 4K0S-N844, 4K0S-P292, 4K0S-S706, 5K0S-T887, 5K0S-T892, 5K0S-Z664, 5K0S-184C, 5K0S-Z654, 5K0S-Z660, 6K0S-437N, 6K0S-834N, 6K0S-015R, 5K0S-160D, 6K0S-815K, 6K0S-022M, 6K0S-757N, 6K0S-504F, 7K0S100578, 6K0S-482K, 6K0S-485K, 6K0S-981P, 6K0S-007Q, 6K0S-805K, 6K0S-777R, 7K0S102982, 7K0S100940, 5K0S-Z666, 6K0S-484J, 6K0S-325L, 6K0S-486J, 6K0S-010M, 7K0S100714, 6K0S-006M, 6K0S-060N, 6K0S-432N, 6K0S-787R, 6K0S-952Q, 7K0S100579, 7K0S107999, 6K0S-017R, 7K0S102656, 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• FEI Number: 3001451489
• Recalling Firm/ Manufacturer: Fresenius Medical Care Holdings, Inc.; 920 Winter St Bld 920; Waltham MA 02451-1521
• For Additional Information Contact: Fresenius Technical Support Services; 800-405-1321
• Manufacturer Reason for Recall: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
• FDA Determined Cause: Component design/selection
• Action: On June 3, 2024 IMPORTANT MEDICAL DEVICE CORRECTION letters were sent to consignees. Fresenius Medical Care is requesting replacement of affected Blood Pump Rotors in 2008K@HOME systems due to the patients possibly being unaware of this component failing. To order for a replacement Blood Pump Rotor (Part Number, F40015481), contact Fresenius Medical Care Customer Service at 800-227-2572, OPTION 3, o Please have Blood Pump Rotor Part Number and Lot Number available when requesting a replacement. CUSTOMER: 1. Please provide this letter to your Biomedical Technician. 2. Report any complaints or adverse events to product.complaints@fmc-na.com or FDA MedWatch at https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting. 3. Provide this Customer Notice to all those who need to be aware within your organization. 4. Complete and return the attached reply form. For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.
• Quantity in Commerce: 1,156 units
• Distribution: Domestic: Nationwide Distribution. International: Canada.
• 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.