What should someone who has this product do?

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Check the product against FDA's description (Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM) and recall number Z-2366-2026, then follow ARROW INTERNATIONAL, LLC's recall instructions.

Has ARROW INTERNATIONAL, LLC had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 47 total FDA actions tied to ARROW INTERNATIONAL, LLC, including 47 recalls and 0 warning letters.

FDA Class I Recall: Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI… by ARROW INTERNATIONAL, LLC

Key facts

Recalling firm	ARROW INTERNATIONAL, LLC
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM
Classification	Class I
Recall number	Z-2366-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	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 serious or life-threatening injuries.

The short version: ARROW INTERNATIONAL, LLC recalled Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM on 2026-06-24. FDA classified this action as a Class I recall (recall number Z-2366-2026). Reason for recall: 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 serious or (additional items listed in FDA's full record). Recall status: Ongoing. This is a device-category FDA recall record.

What this classification means

FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification. In this case, the recalling firm is ARROW INTERNATIONAL, LLC and the affected product is described in FDA's record as: Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM. FDA's stated reason for the recall is: 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 serious or (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2366-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What consumers should do

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Specifically, check whether the product in your possession matches the description on file with FDA -- Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM -- and the recall number Z-2366-2026. If it matches, stop using or distributing it and contact ARROW INTERNATIONAL, LLC or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

ARROW INTERNATIONAL, LLC’s FDA history

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.

Frequently asked questions

What was recalled and why?: ARROW INTERNATIONAL, LLC recalled Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM. FDA's record states the reason for recall as: 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 serious or (additional items listed in FDA's full.
How serious is this recall?: FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification.
What should someone who has this product do?: Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Check the product against FDA's description (Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM) and recall number Z-2366-2026, then follow ARROW INTERNATIONAL, LLC's recall instructions.
Has ARROW INTERNATIONAL, LLC had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 47 total FDA actions tied to ARROW INTERNATIONAL, LLC, including 47 recalls and 0 warning letters.

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Full FDA history for ARROW INTERNATIONAL, LLC

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). FDA Class I Recall: Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI… by ARROW INTERNATIONAL, LLC — Recall Details. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-arrow-international-llc-z-2366-2026

MLA

"FDA Class I Recall: Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI… by ARROW INTERNATIONAL, LLC — Recall Details." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-arrow-international-llc-z-2366-2026.

Chicago

Argus HQ Research. "FDA Class I Recall: Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI… by ARROW INTERNATIONAL, LLC — Recall Details." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/recall/fda-recall-arrow-international-llc-z-2366-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_arrow_international_llc_z_2366_2026_2026,
  title = {FDA Class I Recall: Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI… by ARROW INTERNATIONAL, LLC — Recall Details},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-arrow-international-llc-z-2366-2026},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Recalls ↗