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fda_recall · device_recall · high

Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-…

Event date
2026-09-09 00:00:00Z
Observed
2026-09-15 04:20:27Z
Source ID
Z-3084-2026
Payload hash
e1d9e1c8c67326ae6eeae978…

Summary

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. Status: Ongoing.

Entities

View source record ↗

Frequently asked questions

Has Fresenius Medical Care Renal Therapies Group, LLC had other FDA enforcement actions?
Yes. Argus HQ has recorded 8 total FDA actions tied to Fresenius Medical Care Renal Therapies Group, LLC: 0 warning letters, 8 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-09-09; Argus observed and indexed it on 2026-09-15.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2026). Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: 5008X Standard HD Pre-Flush    Standard Blood Tubing Set    Part Number 03-5110-…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-fresenius-medical-care-renal-therapies-group-llc-z-3084-2026
MLA
"Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: 5008X Standard HD Pre-Flush    Standard Blood Tubing Set    Part Number 03-5110-…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-fresenius-medical-care-renal-therapies-group-llc-z-3084-2026.
Chicago
Argus HQ Research. "Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: 5008X Standard HD Pre-Flush    Standard Blood Tubing Set    Part Number 03-5110-…." Digital Empire Holdings LLC. Accessed September 15, 2026. https://argushq.ai/events/fda-recall-fresenius-medical-care-renal-therapies-group-llc-z-3084-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_fresenius_medical_care_renal_therapies_group_llc_z_3084_2026_2026,
  title = {Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: 5008X Standard HD Pre-Flush    Standard Blood Tubing Set    Part Number 03-5110-…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-fresenius-medical-care-renal-therapies-group-llc-z-3084-2026},
  note = {Accessed: September 15, 2026}
}

Informational only. Not legal, financial, or medical advice.

Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-… · Argus HQ