FDAClass I · Medical device · Recalled June 24, 2026

Description/REF recall — ARROW INTERNATIONAL, LLC

Hazard: 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.

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2370-2026
Brand: ARROW INTERNATIONAL
Classification: Class I
Units affected: 37,738
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

Description/REF

Companies & origin

Recalling firm location: Morrisville, NC, United States
Firm address: 3015 Carrington Mill Blvd, 27560-5437

Identifying details (verbatim from the notice)

Product codes / lots: 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, 33S24A0543, 33F24D0497; ASK-45541-UOI1/10801902193275, 10801902221664/33F25H0411, 33F25J0399, 33S24A1368, 33F26A0226; ASK-45541-VFH1/10801902193275, 10801902218886/33F25B0655, 33F25E0573, 33F25G0210, 33F26A1533, 33F26B0841, 33F25G0584; ASK-45552-UOI1/10801902193275/33F26A0227; ASK-45552-VFH1/10801902193275/33F25D0362, 33F25E0866, 33F25J0226, 33F25M0180, 33F26A1455, 33F25H0408; ASK-45563-UWH1/10801902193275/33F25D0660, 33F25J0227, 33F24K0066; DLX-45541-CURVB/10801902193275/33F25B0385, 33F25D0250, 33F25E0760, 33F25J0336, 33F25K0194, 33F24L1115; DLX-45541-CURVC/10801902193275/33F25B0507, 33F25C0216, 33F25E0761, 33F25F0223, 33F25G0362, 33F25J0337, 33F25E0762; DLX-45541-VPSC/10801902193275, 10801902208610/33F24L0390, 33F24L1130, 33F25C0247, 33F25D0251, 33F25D0380, 33F25D0623, 33F25E0764, 33F25E0900, 33F25F0224, 33F25H0604, 33F25J0445, 33F26A1541, 33F26B0460, 33F26C0220, 33F26C0717, 33F25B0387; DLX-45552-VPSB/10801902193275/33F25C0249, 33F25D0253, 33F25D0314, 33F25D0382, 33F24L0392; DLX-45552-VPSC/10801902193275, 10801902208634/33F24L0939, 33F25B0508, 33F25D0254, 33F25D0315, 33F25D0383,33F25D0626, 33F25E0581, 33F25E0709, 33F25E0835, 33F25J0129, 33F25J0257, 33F25M0167, 33F26B0712, 33F26B0937, 33F25B0388; CDC-35041-VPS/10801902186741, 10801902193275/33X25K0001, 33F25E0425; CDC-05531-PK1A/10801902193275, 60801902123420/33F25C0641, 33F25D0435, 33F25E0646, 33F25J0416, 33F26B0711, 33F25D0765
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.
Firm notified the public via: Letter
FDA event ID: 98793
Recall initiated: April 21, 2026
FDA classified: June 12, 2026
FDA report date: June 24, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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