—#213736

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.

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K231534
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution in the state of Massachusetts.

Timeline

Recall initiated: 2025-04-29
Posted by FDA: 2025-06-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213736. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.