FDAFDA · Food and drugs·Recall number Z-0102-2023
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.
Published October 26, 2022 · Recall initiated: September 14, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Distributor
- US Nationwide distribution in the state of Florida.
- Lot
- UDI (01)10801902144284(17)230731(11)220504(10)13F22C0757
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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