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

FDA device recall Z-1992-2025 · posted 2025-06-18 · Open, Classified

Recall details

Recalling firm

Fresenius Medical Care Holdings, Inc.

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

KDI

Quantity affected

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.

Date initiated

2025-04-29

Date posted

2025-06-18

Location

Waltham, MA

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