5008X HDF Blood Tubing (Fresenius) – Potential Blood Leak (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Fresenius Medical Care Holdings, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Fresenius Medical Care Holdings, Inc. is recalling 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Sta due to Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hem. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026