Class 2 Device Recall CoAxial Introducer Needle

• Date Initiated by Firm: December 10, 2020
• Create Date: February 05, 2021
• Recall Status: Terminated on January 31, 2023
• Recall Number: Z-1076-2021
• Recall Event ID: 87000
• 510(K)Number: K022634
• Product Classification: Introducer, catheter - Product Code DYB
• Product: Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, 1/5F Curved Catheter Sterile EO,
• Code Information: Lot Number: 1394204, 1424962, 1464709, 1473181, 1477229, 1481735, 1495182
• Recalling Firm/ Manufacturer: Argon Medical Devices, Inc; 1445 Flat Creek Rd; Athens TX 75751-5002
• For Additional Information Contact: Rebecca Ellis; 469-731-1410
• Manufacturer Reason for Recall: Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.
• FDA Determined Cause: Process change control
• Action: On 12/11/2020, Argon Medical Devices, Inc. distributed an "Urgent-Product Recall Notice" to all affected consignees via US mail. In addition to informing consignees about the recall device, the firm ask consignees to take the following actions: 1. Complete the response form and return it to us as quickly as possible. This will allow us to begin staging replacement product for you and minimize interruption to service. 2. All affected product should be returned to our Argon Athens facility using RGA#______, attention Arbee Cummings. The mailing address is as follows: RGA# ____, Argon Medical Devices, Inc.1445 Flat Creek Road, Athens, TX 75751 USA 3. Argon Medical will ship your replacement devices as soon as we receive your returned product. Your assistance in accounting for the affected devices in your possession is greatly appreciated. If you have any questions about this letter or about the recall action it describes, please contact Beckie.Ellis@argonmedical.com. You may also contact Ms. Arbee Cummings at Arbee.Cummings@argonmedical.com or Ms. Andrea Wieczor at Andrea.Wieczor@argonmedical.com.
• Quantity in Commerce: 1759 units
• Distribution: US: AL AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX,, UT, VA, WA, WI, WV, WY OUS: Switzerland, Saudi Arabia, Hong Kong, Thailand, Portugal, Taiwan, Austria, Brazil, Netherlands, Italy, Germany, Colombia, Singapore, Canada, View Nam, Slovakia, Spain
• 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 = DYB and Original Applicant = PROMEX, INC.