5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number… — Class II medical device recall Z-3084-2026
Ongoing recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2026-09-09, distributed nationwide. Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or
| Recall number | Z-3084-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA, United States |
| Recall initiated | 2026-08-10 |
| Classified | 2026-09-02 |
| Reported by FDA | 2026-09-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | LT |
| Quantity | 120 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00840861102556 |
| Lot numbers | 25KR01227, 25NR01257 |
| Model numbers | 03-5110-6 |
Product
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Reason for recall
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.
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-3084-2026. 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.