PARACENTESIS KIT — Class I medical device recall Z-2363-2026
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-2363-2026 |
|---|---|
| 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 | 50,724 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10801902138788, 10801902193275, 10801902197938, 10801902197952 |
| Lot numbers | 10801902138788/33F24L0522, 10801902197952/33F24D0004, 33F24A0016, 33F24D0201, 33F24E0166, 33F24G0318, 33F24J0486, 33F24K0083, 33F24L0725, 33F24M0088, 33F25A0453, 33F25A0610, 33F25C0060, 33F25C0749, 33F25C0906, 33F25D0282, 33F25E0031, 33F25F0257, 33F25G0075, 33F25G0746, 33F25H0007, 33F25H0719, 33F25J0602, 33F25J0739, 33F25J0817, 33F25L0462, 33F25M0954, 33F26B0949, 33F26C0575, AK-00376/10801902197938, ASK-00376-VCU/10801902193275 |
| Model numbers | 10801902138788/33F24L0522, 10801902193275, 10801902197938, 10801902197952/33F24D0004, 33F24A0016, 33F24D0201, 33F24E0166, 33F24G0318, 33F24J0486, 33F24K0083, 33F24L0725, 33F24M0088, 33F25A0453, 33F25A0610, 33F25C0060, 33F25C0749, 33F25C0906, 33F25D0282, 33F25E0031, 33F25F0257, 33F25G0075, 33F25G0746, 33F25H0007, 33F25H0719, 33F25J0602 and 10 more |
Product
PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
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-2363-2026. 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.