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: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHS1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU13; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UNHS1 |
| Classification | Class I |
| Recall number | Z-2367-2026 |
| 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. |
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: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHS1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU13; ARROW(R) VPS(R) (additional items listed in FDA's full record). 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-2367-2026 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.
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: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHS1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU13; ARROW(R) VPS(R) (additional items listed in FDA's full record) -- and the recall number Z-2367-2026. 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.
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 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: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHS1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU13; ARROW(R) VPS(R) (additional items listed in FDA's full record)) and recall number Z-2367-2026, then follow ARROW INTERNATIONAL, LLC's.
- 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.
- What is the FDA recall number for this event?
- FDA recall number Z-2367-2026.
- What is the current status of this recall?
- Status as recorded by FDA: Ongoing.
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Related enforcement actions
Full FDA history for ARROW INTERNATIONAL, LLCCompiled 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.
Argus HQ Research (2026). FDA Recall Database: Class I Recall: Description/REF: AGBA PICC G4 Stylet: 3L 6FR x… by ARROW INTERNATIONAL, LLC. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-arrow-international-llc-z-2367-2026
"FDA Recall Database: Class I Recall: Description/REF: AGBA PICC G4 Stylet: 3L 6FR x… by ARROW INTERNATIONAL, LLC." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-arrow-international-llc-z-2367-2026.
Argus HQ Research. "FDA Recall Database: Class I Recall: Description/REF: AGBA PICC G4 Stylet: 3L 6FR x… by ARROW INTERNATIONAL, LLC." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-arrow-international-llc-z-2367-2026.
@misc{argushq_argushq_ai_recall_fda_recall_arrow_international_llc_z_2367_2026_2026,
title = {FDA Recall Database: Class I Recall: Description/REF: AGBA PICC G4 Stylet: 3L 6FR x… by ARROW INTERNATIONAL, LLC},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/recall/fda-recall-arrow-international-llc-z-2367-2026},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Recalls ↗