Fresenius Medical Care Holdings, Inc. recalls 5008X HDF Hemodialysis Blood Tubing Set

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.

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-1992-2025
• FDA 510(k) clearance · K231534The device's official FDA premarket clearance record
• FDA device classification · KDIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5860The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Fresenius Medical Care Holdings, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.