1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Recall
- Recall Number
- Z-0563-2022
- Event Number
- 89439
- Firm
- Argon Medical Devices, Inc
- FEI Number
- 1625425
- Product Code
- GDY
- Status
- Open, Classified
- Root Cause
- Mixed-up of materials/components
- Initiated
- January 24, 2022
- Address
- 1445 Flat Creek Rd, Athens, TX, 75751-5002
Description
1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
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.
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]
US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.
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