Class II — Fresenius Medical Care Holdings, Inc.
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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. |
| Quantity | 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. |
| Initiated | 2025-04-29 |
| Classified | 2025-06-18 |
| Recall number | Z-1992-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Fresenius Medical Care Holdings, Inc. (Z-1992-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96827/
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