ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JH
Summary
The FDA issued a Class II for ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, by ARROW INTERNATIONAL Inc.. Reason: Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 .
Details
Source
Device Recall
External ID
Z-0102-2023
Action Date
2022-10-26
Status
Terminated
Category
device
Product 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.
Lot/Code Info: UDI (01)10801902144284(17)230731(11)220504(10)13F22C0757
Quantity Affected: 18 devices
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).
Distribution
US Nationwide distribution in the state of Florida.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-14
Company
Morrisville, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 184 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ARROW INTERNATIONAL Inc. has 55 FDA actions in our database, including 55 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ARROW INTERNATIONAL Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ARROW INTERNATIONAL Inc. have FDA actions?
ARROW INTERNATIONAL Inc. has 55 FDA actions in our database, including 55 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0102-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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