Description/REF: DRAINAGE KIT/AK-01600 — Class I medical device recall Z-2382-2026
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-2382-2026 |
|---|---|
| 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 | 444,943 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10801902114867, 10801902125726, 10801902145120, 10801902156232, 10801902190915, 10801902193275, 10801902194029, 10801902197952, 10801902203134, 10801902205909, 30801902120190, 30801902120206, 50801902120156, 60801902120160 |
| Lot numbers | 10801902114867/33F24G0390, 10801902145120/33F24A0017, 10801902190915/33F24A0783, 10801902193275/33F24B0805, 10801902194029/33F24C0090, 10801902203134/33F24G0228, 10801902205909/33F24F0656, 30801902120206/33F24A0777, 33F23K0711, 33F24A0015, 33F24A0018, 33F24A0044, 33F24A0348, 33F24A0349, 33F24A0350, 33F24A0351, 33F24A0645, 33F24A0794, 33F24A1005, 33F24A1006, 33F24A1008, 33F24A1070, 33F24A1274, 33F24B0427, 33F24C0091, 33F24C0092, 33F24C0130, 33F24C0930, 33F24D0005, 33F24D0006, 33F24D0007, 33F24D0008, 33F24D0009, 33F24D0010, 33F24D0011, 33F24D0012, 33F24D0066, 33F24D0067, 33F24D0683, 33F24E0032 and 191 more |
| Model numbers | 10801902114867/33F24G0390, 10801902125726, 10801902145120/33F24A0017, 10801902190915/33F24A0783, 10801902193275, 10801902193275/33F24B0805, 10801902194029/33F24C0090, 10801902197952, 10801902203134/33F24G0228, 10801902205909/33F24F0656, 30801902120190, 30801902120206/33F24A0777, 33F23K0711, 33F24A0015, 33F24A0018, 33F24A0044, 33F24A0348, 33F24A0349, 33F24A0350, 33F24A0351, 33F24A0645, 33F24A0794, 33F24A1005, 33F24A1006, 33F24A1008 and 211 more |
Product
Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T, THORACENTESIS KIT/AK-01000, THORACENTESIS KIT/ASK-01000-CHP, DRAINAGE KIT/ASK-01000-NW, THORACENTESIS KIT/ASK-01000-UPMS, PNEUMOTHORAX KIT/AK-01500, PNEUMOTHORAX KIT (NO HEIMLICH VALVE)/ASK-01500, PNEUMOTHORAX KIT/ASK-01500-JCM
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-2382-2026. 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.