1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Summary
The FDA issued a Class II for 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6" by Argon Medical Devices, Inc. Reason: Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay.
Details
Source
Device Recall
External ID
Z-0563-2022
Action Date
2022-02-16
Status
Ongoing
Category
device
Product Description
1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Lot/Code Info: 1. Model: 400115A and Serial # 11377499, Expire Date: 10/27/2022 2. Model: 498100 and Serial # 11378381, Expire Date: 4/15/2026
Quantity Affected: 600 ea
Reason for Recall
Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.
Distribution
US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-24
Company
Athens, TX
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 154 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Argon Medical Devices, Inc has 19 FDA actions in our database, including 7 recalls and 12 clearances.
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 (Argon Medical Devices, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Argon Medical Devices, Inc have FDA actions?
Argon Medical Devices, Inc has 19 FDA actions in our database, including 7 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0563-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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