Description/REF: CVC KIT: 16 GA X 8IN/AK-04210 — Class I medical device recall Z-2396-2026
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-2396-2026 |
|---|---|
| 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 | 35,540 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10801902121582, 10801902121636, 10801902193275, 20801902118787 |
| Lot numbers | 1-L, 10801902193275/33F24A0137, 10801902193275/33F24A1009, 10801902193275/33F24A1257, 33F24A1212, 33F24B0106, 33F24B0382, 33F24B0435, 33F24C0009, 33F24C0255, 33F24C0734, 33F24D0014, 33F24E0572, 33F24E0704, 33F24F0011, 33F24G0224, 33F24G0324, 33F24G0531, 33F24G0684, 33F24H0373, 33F24J0490, 33F24J0648, 33F24K0089, 33F24L0671, 33F24L0731, 33F24M0148, 33F25A0364, 33F25A0456, 33F25A0590, 33F25B0084, 33F25C0899, 33F25C0979, 33F25D0193, 33F25D0693, 33F25E0037, 33F25E0479, 33F25E1039, 33F25H0011, 33F25H0686, 33F25J0461 and 11 more |
| Model numbers | 1-L, 10801902193275/33F24A0137, 10801902193275/33F24A1009, 10801902193275/33F24A1257, 33F24A1212, 33F24B0106, 33F24B0382, 33F24B0435, 33F24C0009, 33F24C0255, 33F24C0734, 33F24D0014, 33F24E0572, 33F24E0704, 33F24F0011, 33F24G0224, 33F24G0324, 33F24G0531, 33F24G0684, 33F24H0373, 33F24J0490, 33F24J0648, 33F24K0089, 33F24L0671, 33F24L0731 and 25 more |
Product
Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-04711
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-2396-2026. 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.