Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS… — Class I medical device recall Z-2370-2026
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-2370-2026 |
|---|---|
| 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 | 37,738 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10801902167696, 10801902186741, 10801902188462, 10801902188479, 10801902193275, 10801902208610, 10801902208634, 10801902208702, 10801902208733, 10801902208764, 10801902208771, 10801902208825, 10801902208856, 10801902218886, 10801902221077, 10801902221664, 60801902123420 |
| Lot numbers | 10801902167696/33F25D0410, 10801902188462/33F25D0067, 10801902188479/33F25G0283, 10801902193275/33F26B0140, 10801902193275/33X25K0001, 10801902208610/33F24L0390, 10801902208634/33F24L0939, 10801902208702/33F25E0506, 10801902208733/33F25B0386, 10801902208764/33F25C0214, 10801902208771/33F25C0337, 10801902208856/33F25D0454, 10801902218886/33F25B0655, 10801902221664/33F25H0411, 33F24D0497, 33F24F0097, 33F24K0066, 33F24L0392, 33F24L0982, 33F24L1080, 33F24L1115, 33F24L1130, 33F24L1148, 33F25A0082, 33F25A0321, 33F25B0387, 33F25B0388, 33F25B0390, 33F25B0508, 33F25B0574, 33F25C0216, 33F25C0247, 33F25C0373, 33F25D0243, 33F25D0245, 33F25D0250, 33F25D0251, 33F25D0253, 33F25D0254, 33F25D0314 and 109 more |
| Model numbers | 10801902167696/33F25D0410, 10801902188462/33F25D0067, 10801902188479/33F25G0283, 10801902193275/33F26B0140, 10801902193275/33X25K0001, 10801902208610/33F24L0390, 10801902208634/33F24L0939, 10801902208702/33F25E0506, 10801902208733/33F25B0386, 10801902208764/33F25C0214, 10801902208771/33F25C0337, 10801902208825, 10801902208856/33F25D0454, 10801902218886/33F25B0655, 10801902221664/33F25H0411, 33F24D0497, 33F24F0097, 33F24K0066, 33F24L0392, 33F24L0982, 33F24L1080, 33F24L1115, 33F24L1130, 33F24L1148, 33F25A0082 and 125 more |
Product
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
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-2370-2026. 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.