5008X Blood Tubing Sets
Fresenius recalls 5008X Blood Tubing Sets over potential online port errors.
Stop using the affected blood tubing sets and contact Fresenius Medical Care for instructions on returning the product and obtaining a replacement.
Recall at a glance
- Quantity recalled
- 113,544 units (4,731 cases)
Why it was recalled
Fresenius Medical Care is recalling certain 5008X Blood Tubing Sets due to potential online port errors from connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product |
|---|
| 03-5110-6 |
| 03-5160-1 |
| 03-5300-3 |
| 03-5300-3C |
| 03-5350-8 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Other recent recalls from Fresenius Medical Care Holdings, Inc.
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification