Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F — Class I medical device recall Z-2373-2026
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-2373-2026 |
|---|---|
| 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 | 15,425 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10801902136470, 10801902136500, 10801902143690, 10801902156379, 10801902168044, 10801902193275, 10801902197129, 10801902198492, 10801902210071, 10801902213478, 10801902213515, 10801902222265, 10801902222319, 30801902123597, 50801902123195, 70801902123328 |
| Lot numbers | 10801902136500/33F25B0239, 10801902143690/33F25F0362, 10801902156379/33F24L1157, 10801902168044/33F25E0652, 10801902197129/33F24G0344, 10801902198492/33F24K0125, 10801902210071/33F25G0562, 10801902213478/33F25E0694, 10801902222265/33F26A1388, 10801902222319/33F26A0008, 33F24A0848, 33F24D0400, 33F24D0693, 33F24D0830, 33F24E0355, 33F24F0041, 33F24G0361, 33F24G0364, 33F24J0511, 33F24J0523, 33F24J0524, 33F24K0126, 33F24K0129, 33F24K0130, 33F24K0560, 33F24K0696, 33F24L0038, 33F24L0279, 33F24L0637, 33F24L0647, 33F24L0649, 33F24L0966, 33F25A0473, 33F25A0482, 33F25A0487, 33F25B0420, 33F25B0427, 33F25C0114, 33F25C0115, 33F25C0117 and 54 more |
| Model numbers | 10801902136470, 10801902136500/33F25B0239, 10801902143690/33F25F0362, 10801902156379/33F24L1157, 10801902168044/33F25E0652, 10801902197129/33F24G0344, 10801902198492/33F24K0125, 10801902210071/33F25G0562, 10801902213478/33F25E0694, 10801902222265/33F26A1388, 10801902222319/33F26A0008, 33F24A0848, 33F24D0400, 33F24D0693, 33F24D0830, 33F24E0355, 33F24F0041, 33F24G0361, 33F24G0364, 33F24J0511, 33F24J0523, 33F24J0524, 33F24K0126, 33F24K0129, 33F24K0130 and 71 more |
Product
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC; HEMODIALYSIS KIT 2L: 14 FR X 20CM AGB/AK-25142-CDC; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UMD; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UNC; HEMODIALYSIS KIT: 2L 14 FR X 20 CM/ASK-25142-UMD; HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB/ASK-25142-UN1; HEMODIALYSIS KIT: 2L 14 FR X 25 CM/ASK-26142-UMD; HEMODIALYSIS KIT: 2LUMEN 12 FR X 13 CM/AU-23122-F; HEMODIALYSIS KIT: 2LUMEN 12 FR X 20 CM/AU-25122-F; HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-X1A; HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-XU1A; HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB/CDC-22142-X1A; HEMODIALYSIS KIT: 2L 12 FR X 25 CM AGB/CDC-26122-X1A; HEMODIALYSIS KIT 2L: 12 FR X 16CM AGB/AK-22122-CDC; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122-F; HEMODIALYSIS KIT: 2-LUMEN 14 FR X 15 CM/AK-22142-F; AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-CN1AU; AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-CN1AC; AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-CN1AU; AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-CN1AU; AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-CN1AC;
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-2373-2026. 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.