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
Summary
The FDA issued a Class I for Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PIC by ARROW INTERNATIONAL, LLC. 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 q.
Details
Source
Device Recall
External ID
Z-2370-2026
Action Date
2026-06-24
Status
Ongoing
Category
device
Product 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
Lot/Code Info: 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
Quantity Affected: 37,738
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-21
Company
Morrisville, NC
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 254 device recalls issued in the same week, part of 413 device-related FDA actions this month.
ARROW INTERNATIONAL, LLC has 50 FDA actions in our database, including 47 recalls and 3 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ARROW INTERNATIONAL, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ARROW INTERNATIONAL, LLC have FDA actions?
ARROW INTERNATIONAL, LLC has 50 FDA actions in our database, including 47 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2370-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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