Recall Z-0563-2022 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
Argon Medical Devices, Inc
1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
| Date | Jan 24, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| 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# provi |
| Quantity | 600 ea |
| Distribution | US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K780871 | ARTERIAL LINE KIT Argon Medical Corp., Jun 14, 1978 |