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fda_recall · device_recall · critical

ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-2…

Event date
2026-06-24 00:00:00Z
Observed
2026-07-09 22:52:01Z
Source ID
Z-2389-2026
Payload hash
bcc62b098c3cab25347548af

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.

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: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-2…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-arrow-international-llc-z-2389-2026
MLA
"ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-2…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-arrow-international-llc-z-2389-2026.
Chicago
Argus HQ Research. "ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-2…." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/events/fda-recall-arrow-international-llc-z-2389-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_arrow_international_llc_z_2389_2026_2026,
  title = {ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-2…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-arrow-international-llc-z-2389-2026},
  note = {Accessed: August 27, 2026}
}

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