1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
FDA Recall Z-0563-2022 · Posted None
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Recalling FirmArgon Medical Devices, Inc
Recall StatusOpen, Classified
Product CodeGDY
Date Initiated2022-01-24
Product Quantity600 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.
Firm 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]
Root Cause
Mixed-up of materials/components
Distribution Pattern
US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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