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U.S. Department of Health and Human Services

Class 2 Device Recall 5008X CAREsystem

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 Class 2 Device Recall 5008X CAREsystemsee related information
Date Initiated by FirmOctober 25, 2025
Date PostedDecember 17, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0936-2026
Recall Event ID 97934
510(K)NumberK243505 
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product5008X CAREsystem +CLiC +CDX;
Code Information Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;
FEI Number 3001451489
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 920
Waltham MA 02451-1521
For Additional Information ContactFresenius Medical Care Customer Service
800-323-5188
Manufacturer Reason
for Recall		Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
FDA Determined
Cause 2		Software design
ActionOn Octiber 25, 2025, customers were called and read a Medical Device Recall Script. Instructions: Please examine the 5008X CAREsystems at your location to confirm that you have any of this product: 1. Please segregate this product until the software update can be performed. 2. Please provide the number of 5008X CAREsystems you have installed at your clinic and the serial numbers of the devices. If the customer has any additional medical concerns or questions, please have them contact Medical Information and Communication: 855-616-2309 or Website: www.freseniusmedinfo.com. 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/medwatchforms-fda-safety-reporting
Quantity in Commerce115 units
DistributionDomestic: LA, MA, MN;
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KDI
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