Z-2346-2024Class II

RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev...

Name: Z-2346-2024 RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2024-06-03
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2024-06-03 / Open, Classified / root cause: design

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A on 2024-06-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2346-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-03
Posted: 2024-07-11
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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.
Root cause tag: design
FDA root 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 [email protected] 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: 2 units
Distribution: Domestic: Nationwide Distribution. International: Canada.
Product codes and lots: Model Number: RTL190904 (Rental Units); UDI/DI: 00840861100965; Serial Numbers: 5K0S193320, 5K0S194164.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2346-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2340-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-11
Z-2341-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-11
Z-2342-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-11
Z-2343-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-11
Z-2344-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-11
Z-2345-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-11
Z-2346-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-11
Z-2347-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-11

Product code KDI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)