Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA… — Class I medical device recall Z-2377-2026

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-2377-2026`
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	126,530
Reason classes	sterility
UPC / GTIN / UDI-DI	`10801902115260`, `10801902121650`, `10801902121674`, `10801902122077`, `10801902168471`, `10801902168488`, `10801902168495`, `10801902168518`, `10801902168532`, `10801902168549`, `10801902168563`, `10801902168570`, `10801902192230`, `10801902193275`, `10801902196719`, `10801902197136`, `10801902209501`, `10801902221909`, `20801902114987`, `30801902122040`, `30801902122248`, `60801902121709`
Lot numbers	`10801902115260/33F25D0263`, `10801902121674/33F24A1010`, `10801902122077/33F24B0190`, `10801902168488/33F24E0342`, `10801902168495/33F24A1020`, `10801902168518/33F24E0177`, `10801902168549/33F24B0194`, `10801902168563/33F24E0714`, `10801902168570/33F24C0738`, `10801902192230/33F24A0846`, `10801902197136/33F24E0347`, `10801902209501/33F24B0437`, `10801902221909/33F25E0590`, `20801902114987/33F25H0640`, `30801902122040/33F24E0344`, `30801902122248/33F24E0178`, `33F23J0175`, `33F23M0175`, `33F24A0146`, `33F24A0355`, `33F24A0401`, `33F24A0408`, `33F24A0796`, `33F24A0813`, `33F24A0849`, `33F24A1014`, `33F24A1268`, `33F24A1269`, `33F24A1619`, `33F24B0112`, `33F24B0174`, `33F24B0187`, `33F24B0191`, `33F24C0013`, `33F24C0025`, `33F24C0093`, `33F24C0094`, `33F24C0104`, `33F24C0107`, `33F24C0548` and 196 more
Model numbers	`1-3/4IN/NA-04020-X1ASP`, `1-LUMEN`, `10801902115260/33F25D0263`, `10801902121674/33F24A1010`, `10801902122077/33F24B0190`, `10801902168488/33F24E0342`, `10801902168495`, `10801902168495/33F24A1020`, `10801902168518/33F24E0177`, `10801902168532`, `10801902168549`, `10801902168549/33F24B0194`, `10801902168563`, `10801902168563/33F24E0714`, `10801902168570/33F24C0738`, `10801902192230/33F24A0846`, `10801902193275`, `10801902197136/33F24E0347`, `10801902209501/33F24B0437`, `10801902221909/33F25E0590`, `20801902114987/33F25H0640`, `20GAX`, `30801902122040/33F24E0344`, `30801902122248/33F24E0178`, `33F23J0175` and 223 more

Product

Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSEL CATH KIT: 20GA X 5IN/AK-04550-S CVC KIT: 1-LUMEN 5 FR X 20 CM/AK-04301-SP CVC KIT: 16 GA X 6IN (16 CM)/AK-04306-SP CVC KIT: 16GA X 6 IN/AK-04800-S CVC KIT: 2-LUMEN 4 FR X 5 CM/AK-12402 CVC KIT: 3-LUMEN 7 FR X 16 CM/AK-12703-CDC CVC KIT: 2L 4 FR X 13 CM/AK-14402 CVC KIT: 2-LUMEN 5 FR X 13 CM/AK-14502 CVC KIT: 3-LUMEN 5.5 FR X 30 CM/AK-14553 CVC KIT: 3-LUMEN 7 FR X 30 CM/AK-14703-SP CVC KIT: 2-LUMEN 4 FR X 8 CM/AK-15402 CVC KIT: 3-LUMEN 5.5 FR X 8 CM/AK-15553 CVC KIT: 2-LUMEN 4 FR X 30 CM/AK-16402 CVC KIT: 3-LUMEN 5.5 FR X 13 CM/AK-16553 CVC KIT: 5 FR X 20 CM/ASK-04301-HH2 CVC KIT 3L: 7 FR X 6 IN (16 CM)/ASK-12703-MGH3

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-2377-2026. 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.