—#191587

Product

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

FDA product code: GDY — Gauze/Sponge, Internal, X-Ray Detectable
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K780871
Affected 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

Why it was recalled

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 (FDA determination)

Mixed-up of materials/components

Action the firm took

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

Recalling firm

Firm: Argon Medical Devices, Inc
Address: 1445 Flat Creek Rd, Athens, Texas 75751-5002

Distribution

Distribution pattern: US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.

Timeline

Recall initiated: 2022-01-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #191587. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.