Home / Recalls / ARROW INTERNATIONAL, LLC / Z-2367-2026

Z-2367-2026 Class I Ongoing

Recalled by ARROW INTERNATIONAL, LLC — Morrisville, NC

Recall Details

Product Type
Devices
Report Date
June 24, 2026
Initiation Date
April 21, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,358

Product Description

Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHS1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU13; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UNHS1

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.

Distribution Pattern

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

Code Information

REF(Material)/UDI-DI/Lot(Batch): DLX-45563-VPSB/10801902193275/33F25C0704, 33F25D0316, 33F25D0627, 33F25M0094, 33F24L0860; DLX-45563-VPSC/10801902193275, 10801902208658, 10801902210118/33F25B0509, 33F25C0340, 33F25D0255, 33F25D0628, 33F25E0767, 33F25E0901, 33F25F0227, 33F25J0448, 33F25K0036, 33F26C0104, 33F26C0107, 33F24C0257; ASK-04001-UCHD1/10801902193275, 10801902219005/33F25H0415, 33F25J0349, 33F26B0440, 33F24L0396; ASK-04001-UCHS1/10801902193275, 10801902219067/33F24L1083, 33F25D0331, 33F25E0521, 33F25E0846, 33F25K0068, 33F25K0107, 33F25M0133, 33F26A1417, 33F26C0029, 33F24K0406; ASK-04001-DU13/10801902193275, 10801902201970/33F25B0514, 33F25C0703, 33F25F0090, 33F25F0124, 33F25H0421, 33F25J0197, 33F26A1372, 33F26B0850, 33F26C0369, 33R25A0227, 33F24K0314; ASK-04001-UNHS1/10801902193275, 10801902211887, 10801902158854/33F25A0229, 33F25C0714, 33F25D0390, 33F25E0847, 33F25G0244, 33F25M0129, 33F26A1139, 33F26C0370, 33F24E0400

Other recalls by ARROW INTERNATIONAL, LLC

  • Z-2393-2026 Class I — Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN ( (April 21, 2026)
  • Z-2376-2026 Class I — Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUME (April 21, 2026)
  • Z-2377-2026 Class I — Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 2 (April 21, 2026)
  • Z-2386-2026 Class I — Description/REF: PARACENTESIS KIT/ASK-00376-JHH (April 21, 2026)
  • Z-2392-2026 Class I — Description/REF: ACCESS TRAY/ASK-04001-MC3 (April 21, 2026)
  • Z-2388-2026 Class I — Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3 (April 21, 2026)
  • Z-2385-2026 Class I — Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 (April 21, 2026)
  • Z-2370-2026 Class I — Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PIC (April 21, 2026)
  • Z-2371-2026 Class I — Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL (April 21, 2026)
  • Z-2378-2026 Class I — Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 (April 21, 2026)