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/DE
Summary
The FDA issued a Class I for Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 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-2378-2026
Action Date
2026-06-24
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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
Quantity Affected: 3,481
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-2378-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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