Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC — Class I medical device recall Z-2391-2026

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-2391-2026`
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	491,489
Reason classes	sterility
UPC / GTIN / UDI-DI	`10801902117639`, `10801902117660`, `10801902117868`, `10801902117899`, `10801902117936`, `10801902118087`, `10801902119916`, `10801902121551`, `10801902130836`, `10801902138788`, `10801902138801`, `10801902139464`, `10801902139709`, `10801902139839`, `10801902140583`, `10801902140606`, `10801902140620`, `10801902140637`, `10801902140644`, `10801902140989`, `10801902142983`, `10801902143805`, `10801902144765`, `10801902145489`, `10801902158854` and 17 more
Lot numbers	`10801902139709/33F24K0212`, `10801902140583/33F24J0208`, `10801902140620/33F25C0491`, `10801902140989/33F24J0163`, `10801902144765/33F24G0417`, `10801902145489/33F24J0144`, `10801902193275/33F23L0771`, `10801902193275/33F23L0976`, `10801902193275/33F23M0171`, `10801902193275/33F23M0188`, `10801902193275/33F24A0112`, `10801902193275/33F24A0117`, `10801902193275/33F24A0142`, `10801902193275/33F24A0359`, `10801902193275/33F24A0380`, `10801902193275/33F24A0814`, `10801902193275/33F24A0983`, `10801902193275/33F24A1057`, `10801902193275/33F24A1699`, `10801902193275/33F24B0144`, `10801902193275/33F24B0463`, `10801902193275/33F24B0869`, `10801902193275/33F24C0780`, `10801902193275/33F24C0971`, `10801902193275/33F24D0201`, `10801902193275/33F24D0518`, `10801902193275/33F24D0584`, `10801902193275/33F24D0733`, `10801902193275/33F24E0400`, `10801902193275/33F24E0454`, `10801902193275/33F24E0648`, `10801902193275/33F24F0213`, `10801902193275/33F24F0619`, `10801902193275/33F24F0685`, `10801902193916/33F24G0275`, `10801902199741/33F24J0138`, `10801902213386/33F24J0303`, `10801902218947/33F24J0341`, `10801902221312/33F24L0072`, `10801902221329/33F24L0073` and 460 more
Model numbers	`1-3/4IN/AK-04020-SPC`, `1-3/4IN/ASK-04020-WBH`, `1/2`, `1/2IN/ASK-01618-AU`, `1/2IN/ASK-01618-RU`, `10801902139709/33F24K0212`, `10801902140583/33F24J0208`, `10801902140620/33F25C0491`, `10801902140989/33F24J0163`, `10801902144765/33F24G0417`, `10801902145489/33F24J0144`, `10801902193275/33F23L0771`, `10801902193275/33F23L0976`, `10801902193275/33F23M0171`, `10801902193275/33F23M0188`, `10801902193275/33F24A0112`, `10801902193275/33F24A0117`, `10801902193275/33F24A0142`, `10801902193275/33F24A0359`, `10801902193275/33F24A0380`, `10801902193275/33F24A0814`, `10801902193275/33F24A0983`, `10801902193275/33F24A1057`, `10801902193275/33F24A1699`, `10801902193275/33F24B0144` and 475 more

Product

Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM5; CATH SL 20 GA X 5 CM HYDROPHILIC/ASK-00520-JH; CATH S-L 20 GA X 5 CM HYDROPHILIC/ASK-00520-UHC; ARTERIAL LINE KIT: 20 GA x 5IN/ASK-00820-CL; RA CATH KIT: 20 GA X 8 CM X 12 CM/ASK-00820-WC; ARTERIAL CATHETERIZATION KIT/ASK-01218-HM; SAC KIT: 20 GA X 12CM/ASK-01220-HMH; ARTERIAL CATH KIT: 20GA X 12CM/ASK-01220-NWM; ARTERIAL CATH KIT: 20 GA X 12 CM/ASK-01220-UH; ARTERIAL CATH: 18 GA X 6 1/2IN/ASK-01618-AU; RA CATH KIT: 18 GA X 6 IN/ASK-01618-CL; ARTERIAL CATH KIT: 18 GA X 6 1/2 IN/ASK-01618-JH; ARTERIAL CATHETERIZATION KIT/ASK-01618-PH; ARTERIAL CATH KIT: 18 GA X 6 1/2IN/ASK-01618-RU; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HF; ARTERIAL CATH KIT: 18 GA X 6 IN (16 CM)/ASK-04018-NS; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-ST; RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04120-BGH; ART/VESS CATH KIT:20GAX4.45CM/20GAX12CM/ASK-04500-SM; ARTERIAL LINE KIT/ASK-04500-UCH; ARTERIAL LINE KIT/ASK-04510-EUH2; ARTERIAL LINE KIT: 20GA X 5IN (12CM)/ASK-04510-MS4; ARTERIAL LINE KIT/ASK-04510-UPM; ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-1A; ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-X1A; ARTERIAL CATH KIT: 22GA X 5CM/SAC-00522-1A ARTERIAL CATH KIT: 22 GA X 5CM/SAC-00522-X1A; ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-1A; ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-X1A; SAC KIT: 18 GA X 12CM/SAC-01218-1A; SAC KIT: 18 GA X 12CM/SAC-01218-X1A; SAC KIT: 20 GA X 12CM/SAC-01220-1A; SAC KIT: 20 GA X 12CM/SAC-01220-X1A; SAC KIT: 18 GA X 16CM/SAC-01618-1A; SAC KIT: 18 GA X 16CM/SAC-01618-X1A; ACCESS TRAY/UM-04018; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-ABM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-BGH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LOL; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MHS; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-MIB3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC1; RA CATH SET: 20 GA X 1 3/4 IN/ASK-04020-URMC; RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04220-FMH1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-1A; RA CATH KIT: 20 GA X 4.45 CM W BIO/NA-04020-B; RA CATH KIT: 20 GA X 4.45 CM W CHG/NA-04020-C; VESSEL CATH KIT: 20 GA X 5IN (12 CM)/ASK-04550-NYP; CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04300-PHP1; CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04301-TJ; ARTERIAL ACCESS KIT/ASK-04001-VAMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-WBH

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-2391-2026. 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.