Has ARROW INTERNATIONAL, LLC had other FDA enforcement actions?

Yes. Argus HQ has recorded 47 total FDA actions tied to ARROW INTERNATIONAL, LLC: 0 warning letters, 47 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 critical severity by Argus HQ. FDA published the underlying record on 2026-06-24; Argus observed and indexed it on 2026-07-09.

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.

.hq

fda_recall · device_recall · critical

ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)…

Name: FDA Recall Record — ARROW INTERNATIONAL, LLC
Creator: Argus HQ
Published: 2026-06-24
License: https://argushq.ai/methodology

Event date: 2026-06-24 00:00:00Z
Observed: 2026-07-09 22:52:05Z
Source ID: Z-2396-2026
Payload hash: a3defabffd46e459f9569c25…

Summary

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to seri… Status: Ongoing.

Entities

ARROW INTERNATIONAL, LLC

View source record ↗

Frequently asked questions

Has ARROW INTERNATIONAL, LLC had other FDA enforcement actions?: Yes. Argus HQ has recorded 47 total FDA actions tied to ARROW INTERNATIONAL, LLC: 0 warning letters, 47 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 critical severity by Argus HQ. FDA published the underlying record on 2026-06-24; Argus observed and indexed it on 2026-07-09.
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). ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-arrow-international-llc-z-2396-2026

MLA

"ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-arrow-international-llc-z-2396-2026.

Chicago

Argus HQ Research. "ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)…." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/events/fda-recall-arrow-international-llc-z-2396-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_arrow_international_llc_z_2396_2026_2026,
  title = {ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-arrow-international-llc-z-2396-2026},
  note = {Accessed: August 27, 2026}
}

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