Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB — Class I medical device recall Z-2367-2026
Ongoing recall by ARROW INTERNATIONAL, LLC, reported 2026-06-24, distributed nationwide. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits an
| Recall number | Z-2367-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ARROW INTERNATIONAL, LLC, Morrisville, NC, United States |
| Recall initiated | 2026-04-21 |
| Classified | 2026-06-12 |
| Reported by FDA | 2026-06-24 |
| Distributed | Nationwide (US) |
| Quantity | 11,358 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10801902158854, 10801902193275, 10801902201970, 10801902208658, 10801902210118, 10801902211887, 10801902219005, 10801902219067 |
| Lot numbers | 10801902158854/33F25A0229, 10801902201970/33F25B0514, 10801902210118/33F25B0509, 10801902219005/33F25H0415, 10801902219067/33F24L1083, 33F24C0257, 33F24E0400, 33F24K0314, 33F24K0406, 33F24L0396, 33F24L0860, 33F25C0340, 33F25C0703, 33F25C0714, 33F25D0255, 33F25D0316, 33F25D0331, 33F25D0390, 33F25D0627, 33F25D0628, 33F25E0521, 33F25E0767, 33F25E0846, 33F25E0847, 33F25E0901, 33F25F0090, 33F25F0124, 33F25F0227, 33F25G0244, 33F25H0421, 33F25J0197, 33F25J0349, 33F25J0448, 33F25K0036, 33F25K0068, 33F25K0107, 33F25M0094, 33F25M0129, 33F25M0133, 33F26A1139 and 15 more |
| Model numbers | 10801902158854/33F25A0229, 10801902201970/33F25B0514, 10801902208658, 10801902210118/33F25B0509, 10801902211887, 10801902219005/33F25H0415, 10801902219067/33F24L1083, 33F24C0257, 33F24E0400, 33F24K0314, 33F24K0406, 33F24L0396, 33F24L0860, 33F25C0340, 33F25C0703, 33F25C0714, 33F25D0255, 33F25D0316, 33F25D0331, 33F25D0390, 33F25D0627, 33F25D0628, 33F25E0521, 33F25E0767, 33F25E0846 and 32 more |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2367-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.