FDAClass IIFebruary 16, 2022

1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 recall

1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"

Why was 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

1. Model: 400115A and Serial # 11377499, Expire Date: 10/27/2022 2. Model: 498100 and Serial # 11378381, Expire Date: 4/15/2026

Product
1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Recalling firm
Argon Medical Devices, Inc
Quantity
600 ea
Distribution
US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.
Recall date
February 16, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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