Z-0563-2022Class II

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

Name: Z-0563-2022 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Creator: Argon Medical Devices, Inc
Published: 2022-01-24
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2022-01-24 / Open, Classified

FDA source

Argon Medical Devices, Inc began a recall of 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6" on 2022-01-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0563-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-24
Posted: 2022-02-04
Recalling firm: Argon Medical Devices, Inc
Product: 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Product code: GDY Gauze/Sponge, Internal, X-Ray Detectable
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.
FDA root cause: Mixed-up of materials/components
Action: Urgent Product Recall Notice was send out to the affected customers on 01/24/2022 via registered mail: The notification letter to each customer identify the specific lots and quantities that were shipped to that customer, and requesting to take the following action by customer. 1. Complete and return product inventory sheet quickly as possible 2. Notify/share the notification with anyone who needs to be aware within your organization or to any organization where the potentially affected products have been transferred. 3. Return all affected product to Argon Athens facility using RGA# provided in the notification. If you have any questions about the recall letter or about the recall action it describes in the notification, please contact [email protected]. You may also contact [email protected] or [email protected]
Quantity in commerce: 600 ea
Distribution: US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.
Product codes and lots: 1. Model: 400115A and Serial # 11377499, Expire Date: 10/27/2022 2. Model: 498100 and Serial # 11378381, Expire Date: 4/15/2026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0563-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0563-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-04

Product code GDY

K780871Class IArterial Line KitArgon Medical Corp. / cleared 1978-06-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)