Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC — Class I medical device recall Z-2378-2026
Ongoing recall by ARROW INTERNATIONAL, LLC, reported 2026-06-24, distributed nationwide. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits an
| Recall number | Z-2378-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ARROW INTERNATIONAL, LLC, Morrisville, NC, United States |
| Recall initiated | 2026-04-21 |
| Classified | 2026-06-12 |
| Reported by FDA | 2026-06-24 |
| Distributed | Nationwide (US) |
| Quantity | 3,481 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10801902140798, 10801902170863, 10801902188332, 10801902193275, 10801902203271, 10801902208849, 10801902216660, 10801902216677, 50801902116715, 50801902120781 |
| Lot numbers | 10801902170863/33F25C0702, 10801902188332/33F25G0003, 10801902193275/33S24A0211, 10801902208849/33F25G0393, 10801902216677/33X25K0002, 33F24D0325, 33F24D0507, 33F24D0604, 33F24J0120, 33F24J0135, 33F24L0285, 33F24L0348, 33F24L0897, 33F25C0699, 33F25D0240, 33F25D0562, 33F25G0260, 33F25G0311, 33F25H0576, 33F25J0437, 33F25L0055, 33F25M0199, 33F26A1534, 33F26A1570, 33F26B0805, 33S24A0529, 50801902116715/33F25H0436, ASK-44552-ABKB/10801902140798, CDC-05542-PK1A/10801902193275, CDC-42563-JX1A/10801902193275, CDC-43063-JX1A/10801902193275, CDC-45541-VPS2/50801902120781, DLX-45541-HPKB/10801902193275 |
| Model numbers | 10801902170863/33F25C0702, 10801902188332/33F25G0003, 10801902193275/33S24A0211, 10801902208849/33F25G0393, 10801902216677/33X25K0002, 33F24D0325, 33F24D0507, 33F24D0604, 33F24J0120, 33F24J0135, 33F24L0285, 33F24L0348, 33F24L0897, 33F25C0699, 33F25D0240, 33F25D0562, 33F25G0260, 33F25G0311, 33F25H0576, 33F25J0437, 33F25L0055, 33F25M0199, 33F26A1534, 33F26A1570, 33F26B0805 and 8 more |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2378-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.