—#217210

Product

5008X CAREsystem +CLiC +CDX;

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K243505
Affected lot / code info: Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

On 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

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Bld 920, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: Domestic: LA, MA, MN;

Timeline

Recall initiated: 2025-10-25
Posted by FDA: 2025-12-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217210. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.