Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F — Class I medical device recall Z-2388-2026
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-2388-2026 |
|---|---|
| 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 | 62,719 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10801902116793, 10801902144956, 10801902159950, 10801902167795, 10801902168525, 10801902193275, 10801902197136, 10801902202281, 10801902213409, 10801902213416, 10801902213423, 10801902213430, 10801902213485, 10801902213492, 10801902213515, 10801902213522, 10801902213539, 10801902213546, 10801902213553, 10801902213560, 10801902213577, 10801902213591, 10801902213614, 10801902213621, 10801902221923 and 9 more |
| Lot numbers | 10801902116793/33F25D0439, 10801902144956/33F25G0172, 10801902159950/33F25E0718, 10801902167795/33F25C0863, 10801902168525/33F24E0348, 10801902193275/33F24D0632, 10801902193275/33F24D0818, 10801902193275/33F24D0842, 10801902193275/33F24D0928, 10801902193275/33F24D0950, 10801902193275/33F24F0084, 10801902193275/33F24F0107, 10801902193275/33F24F0837, 10801902193275/33F24F0929, 10801902193275/33F24F1028, 10801902202281/33F25D0594, 10801902213409/33F25D0554, 10801902213416/33F25J0723, 10801902213485/33F25C0243, 10801902213522/33F25C0240, 10801902213539/33F25A0285, 10801902213546/33F25B0624, 10801902213553/33F25A0312, 10801902213560/33F24L0927, 10801902213577/33F24L0941, 10801902213621/33F25A0309, 10801902222463/33F25E0535, 33F24A0850, 33F24C0461, 33F24D0089, 33F24D0299, 33F24D0396, 33F24E0649, 33F24F0103, 33F24F0758, 33F24F0854, 33F24F0896, 33F24F0998, 33F24F1018, 33F24G0371 and 235 more |
| Model numbers | 10801902116793/33F25D0439, 10801902144956/33F25G0172, 10801902159950/33F25E0718, 10801902167795/33F25C0863, 10801902168525/33F24E0348, 10801902193275, 10801902193275/33F24D0632, 10801902193275/33F24D0818, 10801902193275/33F24D0842, 10801902193275/33F24D0928, 10801902193275/33F24D0950, 10801902193275/33F24F0084, 10801902193275/33F24F0107, 10801902193275/33F24F0837, 10801902193275/33F24F0929, 10801902193275/33F24F1028, 10801902202281/33F25D0594, 10801902213409/33F25D0554, 10801902213416/33F25J0723, 10801902213423, 10801902213485/33F25C0243, 10801902213522/33F25C0240, 10801902213539/33F25A0285, 10801902213546/33F25B0624, 10801902213553/33F25A0312 and 256 more |
Product
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK-12123-UOC1, AHDC KIT: 3-L 12 FR X 16 CM/ASK-12123-UPM, AHDC KIT: 3L 12 FR X 20 CM/ASK-15123-UOC1, AHDC KIT: 3-L 12 FR X 20 CM/ASK-15123-UPM, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-P1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XP1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPCN1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPN1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-P1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPCN1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPN1A, AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPCN1A, HEMODIALYSIS KIT 2L: 12 FR X 20CM AGB/AK-25122-CDC, HEMODIALYSIS KIT: 2-LUMEN 14 FR X 20 CM/AK-25142-F, HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM1, HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM2, AHDC KIT: 2L 14 FR X 15 CM/ASK-22142-UOC1, AHDC AGB KIT: 2-L 14 FR X 15 CM/ASK-22142-UPM, HEMODIALYSIS KIT: 2L 14 FR X 20 CM/ASK-25142-UNC1, AHDC KIT: 2L 14 FR X 20 CM/ASK-25142-UOC1, AHDC AGB KIT: 2L 14 FR X 20 CM/ASK-25142-UPM, HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/ASK-26142-UNC1, HEMODIALYSIS KIT: 2LUMEN 12 FR X 16 CM/AU-22122-F, HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A-U, AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A-U, HEMODIALYSIS KIT 2L: 14 FR X 15 CM AGB/CDC-22142-1A, HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB/CDC-22142-XC1A, AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A-C, AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A-C, AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XCN1A-U, AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XN1A-U, HEMODIALYSIS KIT: 2L 12 FR X 13 CM AGB/CDC-23122-XU1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-X1A, AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A-U, AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XN1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-XU1A, HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB/CDC-25142-1A, HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB/CDC-25142-XC1A, AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A-C, AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A-C, HEMODIALYSIS KIT: 2L 12 FR X 25 CM AGB/CDC-26122-1A, AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XCN1A, AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XN1A, HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/CDC-26142-1A, HEMODIALYSIS KIT: 2L 14 FR X 25 CM AGB/CDC-26142-X1A, AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XCN1A, AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XN1A, HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-25122-F, AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A, LBCVC AGB KIT: 3-L 12 FR X 16 CM/CDC-22123-XCN1A, LBCVC AGB KIT: 3-L 12 FR X 20 CM/CDC-25123-XCN1A, LBCVC AGB KIT:3-L 12 FR X 20 CM/CDC-25123-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-2388-2026. 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.