Z-0734-2023Class II

2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a...

Name: Z-0734-2023 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2022-07-27
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2022-07-27 / Open, Classified / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T... on 2022-07-27. FDA classified it as Class II and gives the reason as "(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0734-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-27
Posted: 2022-12-20
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: (1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm "Remove USB 2 Device".
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Fresenius issued Updated Urgent Medical Device Correction REV B Customer Notification letter (Field Action Number: FA-2020-09-W _REV B) to consignees that have CDX equipped machines on 07-27-2022 via USPS First Class Mail. Letter states reason for recall, health risk and action to take: First, a software issue in SW versions 2.72 and earlier. All machines should be updated to current software (SW version 2.74), pursuant to the July 20, 2021, letter. Second, hardware issue that affects only CDX machines. To reduce the chance of EMI causing a false Remove USB Device 2 alarm from occurring we suggest the following: " Insert a USB device in USB Port 2 that will continually draw current. For example, a blank USB memory stick or a USB powered card reader. o NOTE: DO NOT use passive USB devices in USB Port 2 that go into a suspended state drawing minimal/low current which can trip the sensing circuit. An example would be a USB corded optical mouse. Complete/Return the response form enclosed.
Quantity in commerce: 2008T with CDX= 70,552 2008T Bluestar with CDX= 25,205
Distribution: US Nationwide distribution.
Product codes and lots: Software issue in SW versions 2.72 and earlier with CDX. UDI: (1) 00840861100897; (2) 00840861100910; (3) 00840861102082; (4) 00840861102099

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0734-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0734-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-20

Product code KDI

K173972Class II2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC / cleared 2018-05-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)