Description/REF: ACCESS TRAY/GU-04020 — Class I medical device recall Z-2385-2026
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-2385-2026 |
|---|---|
| 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 | 426,041 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10801902112962, 10801902114065, 10801902115222, 10801902117417, 10801902117516, 10801902117523, 10801902118186, 10801902118193, 10801902118209, 10801902118216, 10801902118407, 10801902118902, 10801902119350, 10801902119435, 10801902119930, 10801902119947, 10801902119954, 10801902119978, 10801902129502, 10801902129953, 10801902136487, 10801902145847, 10801902182545, 10801902189841, 10801902189865 and 24 more |
| Lot numbers | 10801902112962/33F24K0694, 10801902115222/33F24J0115, 10801902117417/33F24B0126, 10801902117523/33F24J0345, 10801902118186/33F25B0432, 10801902118193/33F24K0387, 10801902118209/33F24E0527, 10801902118407/33F24G0500, 10801902118902/33F25E0225, 10801902119947/33F24C0756, 10801902119954/33F24E0740, 10801902119978/33F24A0817, 10801902129502/33F25D0477, 10801902136487/33F24F0710, 10801902145847/33F25H0485, 10801902182545/33F25D0466, 10801902193114/33F25F0334, 10801902193275/33F24D0053, 10801902193275/33F24D0486, 10801902193275/33F24D0713, 10801902193275/33F24E0377, 10801902196412/33F24A1018, 10801902196511/33F25J0291, 10801902200478/33F26A1576, 10801902212006/33F25C0264, 10801902220735/33F25L0025, 10801902220810/33F25H0367, 10801902220827/33F25G0202, 10801902220858/33F25H0413, 10801902224344/33F26A1582, 20801902117506/33F24G0378, 20801902121916/33F24A0356, 30801902118807/33F24C0753, 30801902122255/33F24G0356, 30801902122262/33F24E0082, 33F24A0110, 33F24A0113, 33F24A0239, 33F24A0252, 33F24A0386 and 451 more |
| Model numbers | 10801902112962/33F24K0694, 10801902115222/33F24J0115, 10801902117417/33F24B0126, 10801902117516, 10801902117523/33F24J0345, 10801902118186/33F25B0432, 10801902118193/33F24K0387, 10801902118209/33F24E0527, 10801902118407/33F24G0500, 10801902118902/33F25E0225, 10801902119435, 10801902119947/33F24C0756, 10801902119954/33F24E0740, 10801902119978/33F24A0817, 10801902129502/33F25D0477, 10801902136487/33F24F0710, 10801902145847/33F25H0485, 10801902182545/33F25D0466, 10801902189841, 10801902189865, 10801902193114/33F25F0334, 10801902193275, 10801902193275/33F24D0053, 10801902193275/33F24D0486, 10801902193275/33F24D0713 and 475 more |
Product
Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH; PSI KIT: 9 FR X 10 CM/ASK-09903-PHP1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-UPA; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-YNH; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09907-SL; PSI KIT: 8.5 FR X 4-1/8IN (10 CM)/NA-09803-CDC; PSI KIT: 9 FR X 4-1/8IN (10 CM)/NA-09903-CDC; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL4; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-MGH3; MULTI-LUMEN/PSI KIT/AK-11142-SPCS; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/CDC-11242-1A; MULTI-LUMEN/PSI KIT/AK-11142-D; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-11142-MGH4; MULTI-LUMEN/PSI KIT/NA-11242-CDC; MULTI-LUMEN/PSI KIT/AK-21142-SK; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDTG; MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-RH; MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-IMC; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDTG; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMD; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UU3; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-VCU; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-1A; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-X1A; MULTI-LUMEN/PSI KIT/AK-21242-CDC; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH4; MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-GH1; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-SUU; 2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC4; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UKL; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMF; MULTILUMEN/PSI KIT: 9 FR X 4 1/2 IN/ASK-21242-UR1; PSI KIT: 8.5 FR/AK-29803-CDC; PSI KIT: 9 FR/AK-29903-CDC; PSI KIT: 9 FR/AK-29907-CDC; PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-UN1; PSI KIT: 9 FR/ASK-09903-UM; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDT; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDTG; PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-BID1; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDTG; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UMD; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-UR1; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-X1A; PSI KIT: 8.5 FR X 10 CM/ASK-29803-ECL; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-UPM3; PSI KIT: 9 FR X 10 CM/ASK-29903-ECL; PSI KIT: 9FR X 4IN (10 CM) ANTIMICROBIAL/ASK-29903-UPM3; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09907-TG1
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-2385-2026. 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.