ARROW INTERNATIONAL, LLC recalls Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2

Recalling company

ARROW INTERNATIONAL, LLC

Product

Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS AGBA PICC/DELTA KIT: 1L 4.5 FR X 55 CM/ASK-45541-MHBV PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS/ASK-45552-RH AGBA PICC NaviCurve: 2L 5.5FR x 55CM BP/DLX-45552-CURVB AGBA PICC NaviCurve: 2L 5.5FR x 55CM TCG/DLX-45552-CURVC AGBA PICC: 2L 5.5FR x 55CM w Biopatch/DLX-45552-HPKB AGBA PICC NaviCurve: 3L 6FR x 55CM BP/DLX-45563-CURVB PI PICC KIT: 4 FR X 50 CM/ASK-35041-NH PI PICC KIT: 2-L 5 FR X 50 CM/ASK-35052-NH PI PICC G4 Stylet: 1L 4FR x 55CM w CHG/DLX-35541-VPSC PI PICC NaviCurve: 2L 5FR x 55CM w BP/DLX-35552-CURVB PI PICC NaviCurve: 3L 6FR x 55CM w BP/DLX-35563-CURVB PI PICC G4 Stylet: 3L 6FR x 55CM w BP/DLX-35563-VPSB AGBA PI PICC KIT: 2L 5.5 FR X 55CM/CDC-45552-HPK1A PI AGBA PICC KIT: 3-L 6 FR X 55 CM/CDC-45563-HPK1A PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI1 PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-VFH1 PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI1 PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-VFH1 PI AGBA PICC KIT: 3L 6 FR X 55 CM W/VPS/ASK-45563-UWH1 AGBA PICC NaviCurve: 1L 4.5FR x 55CM BP/DLX-45541-CURVB AGBA PICC NaviCurve: 1L 4.5FR x 55CM TCG/DLX-45541-CURVC AGBA PICC G4 Stylet: 1L 4.5FR x 55CM TCG/DLX-45541-VPSC AGBA PICC G4 Stylet: 2L 5.5FR x 55CM BP/DLX-45552-VPSB AGBA PICC G4 Stylet: 2L 5.5FR x 55CM TCG/DLX-45552-VPSC PI PICC:1L 4FR X 50CM PRELOAD VPS STYLET/CDC-35041-VPS PICC KIT: 3 FR X 55 CM/CDC-05531-PK1A

Reason

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.

Classification

Class I – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

Apr 21, 2026

Reported

Jun 24, 2026

Distribution

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.

Status

Ongoing

Quantity

37,738

Lot / codes

REF(Material)/UDI-DI/Lot(Batch): ASK-44063-NS/10801902193275/33F25F0100; ASK-45052-NS/10801902193275/33F24L0864 ASK-45541-MHBV/10801902193275, 10801902167696/33F25D0410, 33F26C0012, 33S24A0690, 33F25B0574; ASK-45552-RH/10801902193275/33F25B0575, 33F25D0361, 33F25F0197, 33F25K0373, 33F25A0082; DLX-45552-CURVB/10801902193275, 10801902208702/33F25E0506, 33F25E0833, 33F26C0038, 33S24B0518, 33F24L0982; DLX-45552-CURVC/10801902193275, 10801902208733/33F25B0386, 33F25D0381, 33F25D0624, 33F25E0765, 33F25F0225, 33F25H0602, 33F26C0182, 33F25B0390; DLX-45552-HPKB/10801902193275, 10801902208825, 10801902208856/33F25D0454, 33F25D0677, 33F25E0834, 33F25J0446, 33F25M0172, 33F26B0867, 33S24A0586, 33S24A1370, 33F24F0097; DLX-45563-CURVB/10801902193275/33F25C0339, 33F25E0836, 33F25A0321; ASK-35041-NH/10801902221077, 10801902193275/33F26B0140 33F25G0460; ASK-35052-NH/10801902193275/33F25H0412, 33F24L1080; DLX-35541-VPSC/10801902193275/33F25C0449, 33F25D0245, 33F25H0501, 33F24L1148; DLX-35552-CURVB/10801902193275, 10801902208764/33F25C0214, 33F25E0511 ,33F25E0832 ,33F26C0120 33F26C0732, 33F25C0373; DLX-35563-CURVB/10801902193275, 10801902208771/33F25C0337, 33F26B0155, 33F25D0453; DLX-35563-VPSB/10801902193275/33F25C0395; CDC-45552-HPK1A/10801902193275, 10801902188462/33F25D0067, 33F25D0243, 33F25E0452, 33F25E0658, 33F25E0829, 33F26B0891, 33F26C0202, 33S23K0168, 33S24A0419, 33S24A0523, 33S24A1387, 33F25K0317; CDC-45563-HPK1A/10801902193275, 10801902188479/33F25G0283, 33F25H0626, 33

Company location

Morrisville, NC

Recall type

Voluntary: Firm initiated

Recall number

Z-2370-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2370-2026 in the FDA Enforcement Report. Also see FDA recall press releases.