Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP — Class I medical device recall Z-2393-2026

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-2393-2026`
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	72,354
Reason classes	sterility
UPC / GTIN / UDI-DI	`10801902135473`, `10801902141023`, `10801902143874`, `10801902145847`, `10801902193114`, `10801902193275`, `10801902200478`, `10801902211450`, `10801902220698`, `10801902221022`, `10801902221633`, `10801902221930`, `10801902222500`, `10801902222562`, `10801902222746`, `60801902116729`
Lot numbers	`1/8`, `1/8IN`, `10801902193275/33F23K0811`, `10801902193275/33F24B0018`, `10801902193275/33F24D0504`, `10801902193275/33F24D0625`, `10801902193275/33F24D0899`, `10801902193275/33F24E0214`, `10801902211450/33F24L0309`, `10801902220698/33F25C0696`, `10801902221022/33F24H0123`, `10801902221633/33F25E0314`, `10801902221930/33F25E0549`, `10801902222500/33F25D0231`, `10801902222562/33F25D0757`, `10801902222746/33F25F0007`, `33F24B0340`, `33F24E0524`, `33F24F0004`, `33F24F0024`, `33F24F0173`, `33F24F0227`, `33F24F0248`, `33F24F0836`, `33F24F0889`, `33F24G0163`, `33F24G0489`, `33F24H0267`, `33F24H0396`, `33F24H0431`, `33F24H0434`, `33F24J0219`, `33F24J0478`, `33F24K0023`, `33F24L0246`, `33F24L0295`, `33F24L0539`, `33F24M0015`, `33F24M0036`, `33F24M0109` and 139 more
Model numbers	`10801902193275/33F23K0811`, `10801902193275/33F24B0018`, `10801902193275/33F24D0504`, `10801902193275/33F24D0625`, `10801902193275/33F24D0899`, `10801902193275/33F24E0214`, `10801902211450/33F24L0309`, `10801902220698/33F25C0696`, `10801902221022/33F24H0123`, `10801902221633/33F25E0314`, `10801902221930/33F25E0549`, `10801902222500/33F25D0231`, `10801902222562/33F25D0757`, `10801902222746/33F25F0007`, `33F24B0340`, `33F24E0524`, `33F24F0004`, `33F24F0024`, `33F24F0173`, `33F24F0227`, `33F24F0248`, `33F24F0836`, `33F24F0889`, `33F24G0163`, `33F24G0489` and 147 more

Product

Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU5; PSI KIT: 8.5 FR/ASK-09807-UC; PSI KIT: 9 FR X 4 1/8IN (10 CM)/ASK-09903-HH2; PSI KIT: 9 FR X 10 CM/ASK-09903-LMDTG; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU5; PSI KIT: 9 FR X 10 CM/CDC-09903-1A; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-KSF2; MAC TWO LUMEN/PSI KIT: 9 FR X 11.5 CM/ASK-11242-KSF1 AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-MCY1; MULTI LUMEN PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU4; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/ASK-21242-UCD1; 2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-HHC MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDT; PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-CCH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-MM2; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29903-DU1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-HHC; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDT; PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-NWM; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-SL1; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XCN1A; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-HF6; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29804-HHN1; MULTI LUMEN/MAC KIT: 9 FR X 4 IN (10 CM)/ASK-21142-YWH;

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-2393-2026. 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.