FDA-Device2022-10-26Class II
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.
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).
Sold states
US Nationwide distribution in the state of Florida.
Affected count
18 devices
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0102-2023Don't want to check this manually?
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