ARROW INTERNATIONAL Inc. Recall 90871
Description: 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.
ARROW INTERNATIONAL Inc. Recall 90871 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0102-2023 |
| Event ID | 90871 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of Florida. |
| Quantity | 18 devices |
| Recall Reason | 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). |
| Device Classification | 20221026 |
| Device Code Info | UDI (01)10801902144284(17)230731(11)220504(10)13F22C0757 |
| Center Classification Date | 20221019 |
| Recall Initiation Date | 20220914 |
| Recalling Firm | ARROW INTERNATIONAL Inc. |
| Initial Notification | Letter |
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