Fresenius Medical Care Holdings, Inc. recalls 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline,…
- Recall date
- April 29, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1992-2025
- FDA classification
- Class II
- Brand / firm
- Fresenius Medical Care Holdings, Inc.
- Sold / distributed
- US Nationwide distribution in the state of Massachusetts.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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