{"url_path":"/fda/device/recalls/Z-2389-2026","section_key":"summary","section_title":"DEVICE Recall: ARROW INTERNATIONAL, LLC — Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090-SB; SPINAL ANESTHESIA KIT: 24 GA X 9 CM/ASK-24090-SA; SPINAL ANESTHESIA KIT: 25 GA X 9 CM/ASK-24090-SPH; SPINAL ANESTHESIA KIT/ASK-25090-BIDMC; SPINAL ANESTHESIA KIT/ASK-25090-UF","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-21","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2389-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"ARROW INTERNATIONAL, LLC"},"word_count":255,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2389-2026\n\n**Recalling firm:** ARROW INTERNATIONAL, LLC\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-21\n**Report date:** 2026-06-24\n\n## Product\nDescription/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090-SB; SPINAL ANESTHESIA KIT: 24 GA X 9 CM/ASK-24090-SA; SPINAL ANESTHESIA KIT: 25 GA X 9 CM/ASK-24090-SPH; SPINAL ANESTHESIA KIT/ASK-25090-BIDMC; SPINAL ANESTHESIA KIT/ASK-25090-UF\n\n## Reason\nLidocaine, 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.\n\n## Affected lots\nREF(Material)/UDI-DI/Lot(Batch): ASA-24090-SB/10801902193275, 10801902201994/33F24G0383, 33F24K0145, 33F24L0550, 33F25A0491, 33F25C0838, 33F25E0094, 33F25H0044, 33F25J0490, 33F25L0444, 33S25E0094;  ASA-24103-SB/10801902202007, 10801902193275/33F24E0380, 33F24E0381, 33F24G0274, 33F24K0146, 33F24L0696, 33F25A0492, 33F25C0123, 33F25C0774, 33F25E0095, 33F25G0097, 33F25H0045, 33F25J0491, 33F25L0329, 33F26B0494;  ASA-25090-SB/10801902202014, 10801902193275/33F24E0089, 33F24E0090, 33F24G0384, 33F24K0147, 33F24L0545, 33F24L0755, 33F25A0493, 33F25A0621, 33F25B0374, 33F25C0844, 33F25E0097, 33F25G0098, 33F25H0046, 33F25J0850, 33F25K0257;  ASK-24090-SA/10801902202281, 10801902193275/33F24D0396, 33F24E0544, 33F24L0589, 33F25C0182, 33F25C0965, 33F25E0228, 33F25H0146, 33F25J0922, 33F26B0573;  ASK-24090-SPH/10801902202274, 10801902193275/33F24D0397, 33F24G0505, 33F24K0260, 33F24L0654, 33F25A0575, 33F25C0943, 33F25E1026, 33F25H0753, 33F25K0410, 33F26B0501;  ASK-25090-BIDMC/10801902210217/33F24E0546, 33F24E0547, 33F24L0636, 33F25C0183, 33F25C0831, 33F25E0230, 33F25J0923, 33F25L0357;  ASK-25090-UF/10801902206692, 10801902193275/33F24E0548, 33F24L0602, 33F25C0806, 33F25E0231, 33F25G0138, 33F25J0557, 33F25M0957;\n\n## Distribution\nUS Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR."}