ARROW Midline Catheter Kit Mislabeled with Wrong Device Type
ARROW INTERNATIONAL Inc. is recalling an ARROW Pressure Injectable Arrowgard Blue Advance Midline Catheter Kit due to mislabeling. The package labels incorrectly specify a double-lumen 5.5 French catheter, but the kit contains a single-lumen 4.5 French catheter.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with mislabeling where the package contents do not match specifications on the label. The mismatch between the labeled double-lumen 5.5 French catheter and the actual single-lumen 4.5 French catheter creates risk of inappropriate use. No injuries reported, qualifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ARROW INTERNATIONAL Inc. is recalling 18 units of the ARROW Pressure Injectable Arrowgard Blue Advance Midline Kit (Reference ASK-41552-JHVA1) due to mislabeling. The product is a medical device intended for peripheral venous access to support intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.
The affected packages incorrectly display specifications for a double-lumen 5.5 French catheter on the corrugate label, lidstock, banner card, and peel sticker. However, the packages contain a single-lumen 4.5 French catheter. The labeling mismatch includes incorrect priming volumes and kit contents information.
The affected product was distributed in Florida. Clinicians and healthcare facilities that obtained this product should verify the actual device specifications before use to ensure they have the appropriate device for the intended clinical application.
Individuals or healthcare providers who received this product are advised to verify that the actual package contents match the device they intended to obtain, and to contact ARROW INTERNATIONAL Inc. with any questions or concerns regarding this recall.
The recalled product
- 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.
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Hazard
- mis-labeling
- product-mismatch
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI (01)10801902144284(17)230731(11)220504(10)13F22C0757
Distribution
Distributed nationwide across the United States.
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