Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1 — Class I medical device recall Z-2368-2026

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-2368-2026`
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	785,999
Reason classes	sterility
UPC / GTIN / UDI-DI	`10801902114898`, `10801902115024`, `10801902115031`, `10801902115048`, `10801902117622`, `10801902117639`, `10801902117660`, `10801902117837`, `10801902117851`, `10801902117943`, `10801902118001`, `10801902118070`, `10801902119268`, `10801902119930`, `10801902121384`, `10801902121551`, `10801902121582`, `10801902121636`, `10801902130836`, `10801902138498`, `10801902138757`, `10801902139396`, `10801902139976`, `10801902143782`, `10801902143805` and 37 more
Lot numbers	`10801902114898/33F24L0219`, `10801902115024/33F24J0171`, `10801902115024/33F24L0293`, `10801902117639/33F24F0741`, `10801902117660/33F24E0645`, `10801902117837/33F24J0296`, `10801902117851/33F24G0286`, `10801902117943/33F24A0769`, `10801902117943/33F24D0857`, `10801902118001/33F24E0651`, `10801902118070/33F24B0292`, `10801902119268/33F24J0549`, `10801902119930/33F24K0704`, `10801902121384/33F24J0558`, `10801902121551/33F24C0727`, `10801902121551/33F24G0050`, `10801902121582/33F24G0051`, `10801902121636/33F24C0733`, `10801902130836/33F25C0837`, `10801902138498/33F24K0187`, `10801902138757/33F24L0611`, `10801902139396/33F25A0600`, `10801902139976/33F24J0584`, `10801902143782/33F24A1035`, `10801902143805/33F24L0290`, `10801902144550/33F24K0412`, `10801902145571/33F24L1123`, `10801902159776/33F24J0567`, `10801902190939/33F24E0696`, `10801902193244/33F24J0290`, `10801902193275/33F24A0831`, `10801902193275/33F24F0865`, `10801902196719/33F24A0337`, `10801902200454/33F24G0053`, `10801902205916/33F24J0553`, `10801902206814/33F24K0169`, `10801902211429/33F24D0870`, `10801902211429/33F25A0231`, `10801902217018/33F24K0213`, `10801902221602/33F25A0500` and 460 more
Model numbers	`1-1/2`, `1-1/2IN`, `1-1/2IN/AK-04120`, `1-1/2IN/AK-04220`, `1-3/4`, `1-3/4IN`, `1-3/4IN/AK-04018`, `1-3/4IN/AK-04020`, `1-3/4IN/AK-04020-C`, `1-3/4IN/ASK-04020-KSF2`, `1-3/4IN/ASK-04020-MAR`, `1-3/4IN/ASK-04020-PHP`, `1-3/4IN/ASK-04020-RU`, `1-3/4IN/ASK-04020-SHM`, `1-3/4IN/NA-04020-S1A`, `1-3/8IN/AK-04122`, `1/16`, `1/2`, `1/2IN`, `1/2IN/NA-04220-S1A`, `10801902114898/33F24L0219`, `10801902115024/33F24J0171`, `10801902115024/33F24L0293`, `10801902117622`, `10801902117639/33F24F0741` and 475 more

Product

Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A; ARTERIAL LINE KIT/AK-04510-S; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HUMC; ARTERIAL LINE KIT: 18 GA X 6 IN (16 CM)/ASK-04018-OH1; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-BID; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-MAR; ARTERIAL LINE KIT: 20 GA X 5 IN/ASK-04020-PM4; RA CATH KIT: 20 GA X 1 1/2IN (3.81 CM)/ASK-04120-HF3; RA CATH SET: 20 GA X 2 1/2 IN (6.35 CM)/ASK-04120-UR; ARTERIAL CATH KIT: 20 GA X 3 1/16 IN/ASK-04125-MGH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04500-HFH4; ARTERIAL LINE KIT: 20GA X 5IN/ASK-04510-BID2; ARTERIAL LINE KIT: 20GA X 5IN (12 CM)/ASK-04510-EHP1; ARTERIAL LINE KIT/ASK-04510-FEM1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-HFH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04510-HFH4; ARTERIAL LINE KIT/ASK-04510-SE; ARTERIAL LINE KIT: 20 GA X 5 IN (12CM)/ASK-04510-TGH2; RA CATH KIT: 20 GA X 12 CM/NA-04550-1A; RA CATH KIT: 20 GA X 12 CM/NA-04550-X1A; RA CATH KIT: 18 GA X 1-3/4IN/AK-04018; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-C; RA CATH KIT: 20 GA X 1-1/2IN/AK-04120; RA CATH KIT: 22 GA X 1-3/8IN/AK-04122; RA CATH KIT: 20 GA X 1-1/2IN/AK-04220; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-AH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-ATH; RA CATH KIT: 20 GA X 1 3/4IN (4.45CM)/ASK-04020-AU2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-BHS; ARTERIAL CATHETERIZATION KIT/ASK-04020-BIDB2; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-CCD1; ARTERIAL CATHETERIZATION KIT/ASK-04020-CR; ART LINE KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-EUH2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FAM1; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FMC; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-KSF2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LM; RA CATH KIT: 20 GA X 1 3/4IN/ASK-04020-MCH1; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MIH1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-NWMX; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-PHP; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-RIHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-RMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-RU; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-SE; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-SHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-SRMC1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UCL1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-UMI; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-UN; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC1; RA CATH SET: 20 GA X 1-1/2IN (3.81CM)/ASK-04220-PSU; RA CATH KIT: 20 GA X 1-1/2 IN (3.81 CM)/ASK-04220-UCL1; RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-S1A; CVC KIT: 20 GA X 5 IN (12CM)/ASK-04550-JMC1; ARTERIAL ACCESS TRAY/ASK-04001-BW2; ARTERIAL ACCESS TRAY WITH .025 IN SWG/ASK-04001-WUH1; ARTERIAL LINE KIT/ASK-04510-HUM

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-2368-2026. 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.