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fda_recall · device_recall · high

Baxter Healthcare Corporation — Class II recall: Baxter Solution Set with Duo-Vent Spike, REF 2R8404

Event date
2025-01-29 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-1009-2025
Payload hash
047a0167f74a85514a8cbd9b

Summary

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable. Status: Ongoing.

Frequently asked questions

Has Baxter Healthcare Corporation had other FDA enforcement actions?
Yes. Argus HQ has recorded 208 total FDA actions tied to Baxter Healthcare Corporation: 0 warning letters, 208 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 2025-01-29; Argus observed and indexed it on 2026-07-16.
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 (2025). Baxter Healthcare Corporation — Class II recall: Baxter Solution Set with Duo-Vent Spike, REF 2R8404. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1009-2025
MLA
"Baxter Healthcare Corporation — Class II recall: Baxter Solution Set with Duo-Vent Spike, REF 2R8404." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1009-2025.
Chicago
Argus HQ Research. "Baxter Healthcare Corporation — Class II recall: Baxter Solution Set with Duo-Vent Spike, REF 2R8404." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1009-2025.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_baxter_healthcare_corporation_z_1009_2025_2025,
  title = {Baxter Healthcare Corporation — Class II recall: Baxter Solution Set with Duo-Vent Spike, REF 2R8404},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1009-2025},
  note = {Accessed: July 23, 2026}
}

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