FDA Device recall Z-2373-2026
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F
- FDA Device
- Class I
- ongoing
- Published 2026-06-24
On 2026-06-24 the FDA classified a Class I recall of Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F by Arrow International, citing 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 rep….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2373-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-04-21 |
| Published | 2026-06-24 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Arrow International |
| Distribution | US |
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
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.
Identifiers
| code_info | REF(Material)/UDI-DI/Lot(Batch): AK-11802-F/10801902193275, 10801902197129/33F24G0344, 33F24J0511, 33F24L0637, 33F25A04…REF(Material)/UDI-DI/Lot(Batch): AK-11802-F/10801902193275, 10801902197129/33F24G0344, 33F24J0511, 33F24L0637, 33F25A0473, 33F25E0060, 33F25J0473, 33F24A0848; AK-22122/10801902193275/33F24H0232, 33F24J0523; AK-22142-CDC/10801902193275/33F24J0527, 33F24K0129, 33F24L0649, 33F25C0115, 33F25C0959, 33F25E0940, 33F25J0481, 33F25L0428, 33F24G0364; AK-25142-CDC/10801902193275, 50801902123195/33F25A0486, 33F25C0892, 33F25E0086, 33F25E0944, 33F25J0485, 33F25J0845, 33F25L0374, 33F26B0521, 33F25A0487; ASK-22142-UMD/10801902193275, 10801902136470, 10801902143690/33F25F0362, 33F25J0094, 33F26A0244, 33F26B0137, 33F24F0041; ASK-22142-UNC/10801902193275/33F25G0269, 33F24K0560; ASK-25142-UMD/10801902193275, 10801902136500/33F25B0239, 33F25E0308, 33F25G0686, 33F25K0425, 33F26A0246, 33F26C0047, 33F24K0696; ASK-25142-UN1/10801902193275, 10801902156379/33F24L1157, 33F26B0908, 33F25B0420; ASK-26142-UMD/10801902193275, 33F26A0408, 33F25B0427; AU-23122-F/10801902193275/33F25C0877, 33F25H0157, 33F24L00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2373-2026%22
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