Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR x 55CM w Biopatch/DLX-45541-HPKB; PICC/DELTA KIT: 2L 5.5 FR X 50 CM/ASK-45052-MC; AGBA PI PICC KIT: 1L 4.5FR 40CM/CDC-44041-HPK1A; AGBA PI PICC KIT 2-LUMEN: 5.5 FR X 40CM/CDC-44052-HPK1A; AGBA PICC/DELTA FG: 2-L 5.5 FR X 40 CM/CDC-44052-VPS2; PI AGBA PICC KIT: 3-L 6 FR X 50 CM/CDC-45063-HPK1A; AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM/CDC-45541-VPS2; AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM/CDC-45552-VPS2; PICC/VPS 1L 4.5 FR/ASK-45541-CHS; PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI2; PICC KIT: 2L 5.5FR 55CM AGBA VPS/ASK-45552-CHS; PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI2; PICC KIT: 3L 6FR 55CM AGBA/ASK-45563-CHS; PI JACC KIT: 3L 6 FR X 25 CM CG+/ASK-42563-LTAC; PI JACC KIT: 1-L 4.5 FR X 25 CM CG+/CDC-42541-JX1A; PI JACC KIT: 2-L 5.5 FR X 25 CM CG+/CDC-42552-JX1A; PI JACC KIT: 3-L 6 FR X 25 CM CG+/CDC-42563-JX1A; PI JACC KIT: 2-L 5.5 FR X 30 CM CG+/CDC-43052-JX1A; PI JACC KIT: 3-LUMEN: 6 FR X 30 CM CG+/CDC-43063-JX1A; PICC KIT: 2-L 4 FR X 55 CM/CDC-05542-PK1A

Class I

Recalling firm: ARROW INTERNATIONAL, LLC
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.
Affected products (lot / model / serial): REF(Material)/UDI-DI/Lot(Batch): DLX-35563-HPKC/10801902193275/33F25D0520; ASK-44552-ABKB/10801902140798, 10801902216677/33X25K0002, 33S24A0529; ASK-45552-MHBV/10801902193275/33F25K0372, 33F25M0199, 33F26A1534, 33F24L0348; DLX-45541-HPKB/10801902193275, 10801902208849/33F25G0393, 33F25L0055, 33F26A1570, 33F24D0604; ASK-45052-MC/10801902216660/33S24A1242; CDC-44041-HPK1A/10801902193275/33F24K0430; CDC-44052-HPK1A/10801902193275/33F25D0241; CDC-44052-VPS2/10801902193275/33F25E0514; CDC-45063-HPK1A/10801902193275/33F25D0242; CDC-45541-VPS2/50801902120781, 10801902193275/33S24A0211, 33F25C0699; CDC-45552-VPS2/10801902193275/33F25E0704; ASK-45541-CHS/10801902193275/33F26A1422, 33F24L0897; ASK-45541-UOI2/10801902193275/33F24L0991; ASK-45552-CHS/10801902193275/33F26A1395, 33F25G0260; ASK-45552-UOI2/10801902193275/33F24L0431; ASK-45563-CHS/10801902193275/33F25A0199; ASK-42563-LTAC/10801902203271/33F24F0852; CDC-42541-JX1A/10801902193275/33F26A1469, 33F24J0135; CDC-42552-JX1A/10801902193275/33F25D0561, 33F24L0285; CDC-42563-JX1A/10801902193275, 10801902170863/33F25C0702, 33F25D0562, 33F25G0311, 33F25J0437, 33F24D0507; CDC-43052-JX1A/10801902193275/33F25M0062, 33F24J0120; CDC-43063-JX1A/10801902193275, 10801902188332/33F25G0003, 33F26B0805, 33F25D0240; CDC-05542-PK1A/10801902193275, 50801902116715/33F25H0436, 33F25H0576, 33F24D0325
Units affected: 3,481
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.
Firm location: Morrisville, NC, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-2378-2026
Recall initiated: April 21, 2026
FDA classification date: June 12, 2026
FDA report date: June 24, 2026
FDA event ID: 98793
Last updated on HTM Vibe: July 23, 2026

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