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U.S. Department of Health and Human Services

Class 2 Device Recall 2008 Series Hemodialysis machines, Spare Part

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  Class 2 Device Recall 2008 Series Hemodialysis machines, Spare Part see related information
Date Initiated by Firm April 17, 2024
Date Posted May 17, 2024
Recall Status1 Open3, Classified
Recall Number Z-1866-2024
Recall Event ID 94463
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Blood Pump Rotor, Model Number: F40015481 Rev A
Code Information Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots.
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 2		 Device Design
Action On April 17, 2024 IMPORTANT MEDICAL DEVICE CORRECTION letters were sent to customers. Customer actions: As per the 2008T Operators Manual P/N 490122 Rev AA: Blood Pump Rotors should be inspected for proper operation, as stated in Chapter 2: Daily preparation for treatment. If you experience a dislodged guide post sleeve, bent or loose tubing guide posts, or roller cannot move freely on your current F40015481 Rev A blood pump rotor, please contact FMCRTG Technical Support Services at 800-405-1321 for a replacement Blood Pump Rotor (Part Number, F40015481, Rev C) . Have Rotor Lot Number available when requesting a replacement. Please provide this letter to your Biomedical Technician or trained personnel. 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. Provide this Customer Notice to all those who need to be aware within your organization. Complete and return the attached reply form. Biomedical Technician/ actions: A Field Service Bulletin will be posted to fmcna.com website regarding Preventative Maintenance activities for Blood Pump Rotor Tubing Guide Inspection of the need to inspect the blood pump tubing guides during the 6-month Preventive Maintenance on all 2008 Series Hemodialysis Machines. URL: https://fmcna.com/support/product-support-documents/field-service-bulletins/ For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.
Quantity in Commerce 45,880 components
Distribution US Nationwide distribution.
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.
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