Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC — Class I medical device recall Z-2374-2026
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-2374-2026 |
|---|---|
| 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 | 4,270 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10801902168471, 10801902168532, 10801902186499, 10801902193275, 10801902196498, 10801902213430, 30801902111822, 40801902111867, 50801902123515 |
| Lot numbers | 10801902168471/33F24J0419, 10801902168532/33F24G0140, 10801902196498/33F25J0113, 10801902213430/33F25D0438, 33F24A0767, 33F24D0355, 33F24D0974, 33F24E0175, 33F24J0449, 33F24L0469, 33F24M0074, 33F25B0015, 33F25B0040, 33F25B0621, 33F25E0649, 33F25F0022, 33F25G0291, 33F25G0482, 33F25H0578, 33F25H0579, 33F25J0029, 33F25J0313, 33F25J0604, 33F25K0268, 33F26B0056, 33F26B0161, 33F26C0190, 33F26C0198, 40801902111867/33F25D0612, AK-12123-PCDC/10801902193275, AK-15123-PCDC/10801902186499, CDC-15123-XP1A/10801902193275, CDC-16123-XP1A/10801902193275, CDC-16123-XPN1A/10801902193275 |
| Model numbers | 10801902168471/33F24J0419, 10801902168532/33F24G0140, 10801902193275, 10801902196498/33F25J0113, 10801902213430/33F25D0438, 30801902111822, 33F24A0767, 33F24D0355, 33F24D0974, 33F24E0175, 33F24J0449, 33F24L0469, 33F24M0074, 33F25B0015, 33F25B0040, 33F25B0621, 33F25E0649, 33F25F0022, 33F25G0291, 33F25G0482, 33F25H0578, 33F25H0579, 33F25J0029, 33F25J0313, 33F25J0604 and 11 more |
Product
Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPN1A; AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-XN1A-U; LBCVC AGB KIT: 3-L 12 FR X 16 CM/CDC-22123-XN1A
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-2374-2026. 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.