5008X HDF Hemodialysis Blood Tubing Set — Class II medical device recall Z-1992-2025
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2025-06-25, distributed nationwide. Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodia
| Recall number | Z-1992-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2025-04-29 |
| Classified | 2025-06-18 |
| Reported by FDA | 2025-06-25 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00840861102365, 00840861102389, 10840861102362, 10840861102379, 10840861102386 |
| Lot numbers | 24LR01214, 24LR01215, 24LR01216, 24SR01010, 24SR01011, 24SR01012, 25ER01800, 25ER01804, 25ER01805 |
| Model numbers | 03-5100-7, 03-5100-7C, 03-5150-2, 5008X |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1992-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.