FDA Device recall Z-1992-2025
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-51…
- FDA Device
- Class II
- ongoing
- Published 2025-06-25
On 2025-06-25 the FDA classified a Class II recall of 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-51… by Fresenius Medical Care Holdings, citing potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolate….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1992-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-29 |
| Published | 2025-06-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | a. Model Number: 03-5100-7; UDI-DI: 00840861102365 (Bag), 10840861102362 (Case); Lot Numbers: 24LR01214, 24SR01010, 25E…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. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1992-2025%22
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