ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline… — Class II medical device recall Z-0102-2023
Terminated recall by ARROW INTERNATIONAL Inc., reported 2022-10-26, distributed nationwide. Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product in
| Recall number | Z-0102-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ARROW INTERNATIONAL Inc., Morrisville, NC, United States |
| Recall initiated | 2022-09-14 |
| Classified | 2022-10-19 |
| Reported by FDA | 2022-10-26 |
| Terminated | 2024-01-19 |
| Distributed | Nationwide (US) |
| Quantity | 18 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10801902144284 |
| Model numbers | ASK-41552-JHVA1 |
Product
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.
Reason for recall
Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1).
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-0102-2023. 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.