FDA Device recall Z-3084-2026
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
- FDA Device
- Class II
- ongoing
- Published 2026-09-09
On 2026-09-09 the FDA classified a Class II recall of 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 by Fresenius Medical Care Renal Therapies Group, citing heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3084-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-10 |
| Published | 2026-09-09 |
| Last updated | 2026-09-15 05:30 UTC |
| Company | Fresenius Medical Care Renal Therapies Group |
| Distribution | US |
Product
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Reason
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
Identifiers
| code_info | Lots 25KR01227 25NR01257 UDI-DI 00840861102556 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-15 05:30 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-09-30 · Fresenius Medical Care Renal Therapies Group - 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 1…
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
All Fresenius Medical Care Renal Therapies Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3084-2026%22
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