Class 2 Device Recall Arterial Line Kit

• Date Initiated by Firm: April 08, 2020
• Create Date: May 08, 2020
• Recall Status: Terminated on December 14, 2022
• Recall Number: Z-1936-2020
• Recall Event ID: 85488
• 510(K)Number: K780871
• Product Classification: Gauze/sponge, internal, x-ray detectable - Product Code GDY
• Product: Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required.; ; Case Label: Arterial Line Kit 20ga x 3", Ref 498411B, Qty: 10/CS
• Code Information: Lot: 11299236
• Recalling Firm/ Manufacturer: Argon Medical Devices, Inc; 1445 Flat Creek Rd; Athens TX 75751-5002
• For Additional Information Contact: Rebecca Ellis; 903-675-9321
• Manufacturer Reason for Recall: Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.
• FDA Determined Cause: Under Investigation by firm
• Action: Argon Medical Devices, Inc. sent Urgent Medical Device Recall letters, dated April 7, 2020 by mail on April 8th to the affected customer/hospital/distributors. The letter states they shipped Arterial Line Kits that include a different suture set than what is normally packaged in the kits the customers order. The kits customers normally order include a straight-cutting needle with a 3-0 silk suture. The kits customers recently received from them include a curved reverse-cutting needle with a 0-silk suture. A list of the affected product numbers is provided in the letter. They immediately corrected the production error that created this situation and reestablished their supply of Arterial Line Kits with the correct suture set. If customers would like to exchange the Arterial Line Kits they received for kits containing the correct suture set, they will gladly exchange these kits at no cost. Conversely, they understand the rise of the recent COVID-19 pandemic put Arterial Line Kits in high demand in the United States. Therefore, they do not require customers to return the affected Arterial Line Kits if they would prefer to use them as-is. To facilitate an exchange of the product received customers can contact Argon Medical Customer Service at 1-800-927-4669 or customer.service@argonmedical.com. If customers would prefer to use the product as-is, no further action is necessary. The letter included a form for customers to acknowledge receipt and account for product inventory and submit for exchange if they wish.
• Quantity in Commerce: 150
• Distribution: US Nationwide distribution including the states of CA, IL, ND, SC, TX, VA. OUS: None
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GDY and Original Applicant = ARGON MEDICAL CORP.