Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH — Class I medical device recall Z-2369-2026

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-2369-2026`
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	348,684
Reason classes	sterility
UPC / GTIN / UDI-DI	`10801902112986`, `10801902114065`, `10801902114881`, `10801902118407`, `10801902129502`, `10801902129953`, `10801902134964`, `10801902136678`, `10801902139365`, `10801902143874`, `10801902144512`, `10801902156348`, `10801902158878`, `10801902159479`, `10801902159530`, `10801902159622`, `10801902159639`, `10801902160086`, `10801902160987`, `10801902161830`, `10801902182545`, `10801902188899`, `10801902189674`, `10801902193121`, `10801902193190` and 35 more
Lot numbers	`1/8`, `10801902112986/33F25E0551`, `10801902114065/33F25D0349`, `10801902114881/33F25B0428`, `10801902118407/33F24D0797`, `10801902129953/33F25E1194`, `10801902134964/33F25B0643`, `10801902136678/33F25A0437`, `10801902143874/33F24M0171`, `10801902144512/33F25J0385`, `10801902156348/33F24E0637`, `10801902156348/33F24H0146`, `10801902159479/33F24J0014`, `10801902159622/33F25F0184`, `10801902160987/33F24F0965`, `10801902193190/33F25J0679`, `10801902193206/33F25B0532`, `10801902193275/33F24D0050`, `10801902193275/33F24E0226`, `10801902193275/33F24E0326`, `10801902193275/33F24E0615`, `10801902193275/33F24F0025`, `10801902193275/33F24F0742`, `10801902193275/33F24F0756`, `10801902193275/33F24F0767`, `10801902193275/33F24F0800`, `10801902193275/33F24F0808`, `10801902193275/33F24F0994`, `10801902193275/33F24F1006`, `10801902193275/33F24G0022`, `10801902196436/33F24J0117`, `10801902196511/33F24D0427`, `10801902200492/33F24F0921`, `10801902200492/33F25B0642`, `10801902206685/33F25B0242`, `10801902211443/33F25A0213`, `10801902217087/33F24L0322`, `10801902220339/33F24L1014`, `10801902220728/33F25A0041`, `10801902225136/33F24L0227` and 460 more
Model numbers	`10801902112986/33F25E0551`, `10801902114065/33F25D0349`, `10801902114881/33F25B0428`, `10801902118407/33F24D0797`, `10801902129953/33F25E1194`, `10801902134964/33F25B0643`, `10801902136678/33F25A0437`, `10801902139365`, `10801902143874/33F24M0171`, `10801902144512/33F25J0385`, `10801902156348/33F24E0637`, `10801902156348/33F24H0146`, `10801902158878`, `10801902159479/33F24J0014`, `10801902159530`, `10801902159622/33F25F0184`, `10801902159639`, `10801902160086`, `10801902160987/33F24F0965`, `10801902161830`, `10801902188899`, `10801902193121`, `10801902193190/33F25J0679`, `10801902193206/33F25B0532`, `10801902193275` and 475 more

Product

Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4; PSI/CVC KIT: 9 FR/7 FR X 6IN (16CM)/ASK-09903-AMC1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-CMC1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU4; PSI KIT: 9 FR X 4 1/8 IN (10CM)/ASK-09903-PCMH1; PSI KIT: 8.5 FR X 10 CM/CDC-09803-1A; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL3; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-PHP2; MULTI LUMEN/PSI KIT/ASK-11142-NSU; MULTI-LUMEN/PSI KIT/AK-21242-X; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-DMC; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-GMC1; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-HF5; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDT; 2L MAC KIT: 9 FR DISTAL X 4IN (10 CM)/ASK-21142-UCL1; 2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-SL1; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMH; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UN1; MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB/CDC-21142-XCN1A; MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB/CDC-21142-XN1A; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-XCN1A; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-XN1A; 2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-CO1; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH3; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-OHSU3; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-SG2; MULTILUMEN/MAC KIT: 9 FR X 4 IN (10 CM)/ASK-21142-UOI1; 2 LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-WHC2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-BID1; AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-BSWH2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-DU1; MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-PCMH1; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UCH2; AGB MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UHC2; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-BSWH2; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-HHC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-MCY1; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-UPM1; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29804-VCU; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-MCY1; PSI KIT: 9 FR/ASK-29903-MHI; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-OHU4; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-UCH2; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UCL1; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UHC4; PSI KIT: 9FR X 4IN (10 CM) ANTIMICROBIAL/ASK-29903-UPM1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29907-LGH; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-X1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-XCN1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-XN1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-AHH; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XN1A; PSI ACCESS TRAY/ASK-04001-MM2; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-GMC; MULTI LUMEN/PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU3

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-2369-2026. 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.