1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
- Company
- Argon Medical Devices, Inc
- Recall Initiated
- January 24, 2022
- Recall Number
- Z-0563-2022
- Quantity
- 600 ea
- Firm Location
- Athens, TX
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.
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
Root Cause
Mixed-up of materials/components
Action Taken
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 Brian.Rogers@argonmedical.com. You may also contact Arbee.Cummings@argonmedical.com or Andrea.Wieczor@argonmedical.com