Z-1992-2025Class II

5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF...

Name: Z-1992-2025 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2025-04-29
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2025-04-29 / Open, Classified / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X... on 2025-04-29. FDA classified it as Class II and gives the reason as "Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration". 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-1992-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-29
Posted: 2025-06-18
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Fresenius Medical Care notified its single consignee on 04/29/2025 via telephone call. The consignee was made aware of the issue and affected units and instructed to examine their inventory for those affected units. If they had any affected units, they were instructed to remove them from their inventory immediately and provide contact information to arrange for their return. On 05/14/2025, Fresenius Medical Care expanded the recall to include additional lot numbers and notified consignees. The notification was via telephone call and included the same instructions as the initial letter but included the additional lots. On 06/05/2025, Fresenius Medical Care expanded the recall again to include additional lot numbers and notified consignees. The notification was via telephone call and included the same instructions as the initial letter but included the additional lots. A recall notification letter was sent to the consignee on about 06/23/2025. The letter provided the same information as was verbally communicated in notifications.
Quantity in commerce: Model Number, Cases (Eaches): 03-5100-7, 76 (1,824); 03-5100-7C, 5 (120); 03-5150-2, 8 (192)
Distribution: US Nationwide distribution in the state of Massachusetts.
Product codes and lots: a. Model Number: 03-5100-7; UDI-DI: 00840861102365 (Bag), 10840861102362 (Case); Lot Numbers: 24LR01214, 24SR01010, 25ER01800. b. Model Number: 03-5100-7C; UDI-DI: 0084086110237 (Bag), 10840861102379 (Case); Lot Number: 24LR01215, 24SR01011, 25ER01804. c. Model Number: 03-5150-2; UDI-DI: 00840861102389 (Bag), 10840861102386 (Case); Lot Number: 24LR01216, 24SR01012, 25ER01805.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1992-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1992-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-25	2025-06-18

Product code KDI

K231534Class II5008X Hemodialysis SystemFresenius Medical Care / cleared 2024-02-02

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)