Class 2 Device Recall LCATH PICC S/L Peripherally Inserted Central Catheter

• Date Initiated by Firm: June 14, 2024
• Date Posted: August 16, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2638-2024
• Recall Event ID: 94951
• 510(K)Number: K230669
• Product Classification: Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
• Product: L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
• Code Information: UDI-DI: 20886333209938, 00886333209934. Lot: 11563923. Expiration: 2027-03-11
• FEI Number: 1625425
• Recalling Firm/ Manufacturer: Argon Medical Devices, Inc; 1445 Flat Creek Rd; Athens TX 75751-5002
• For Additional Information Contact: 469-430-0546
• Manufacturer Reason for Recall: Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay.
• FDA Determined Cause: Employee error
• Action: On 6/14/24,"URGENT PRODUCT RECALL NOTICE"s were emailed to Physicians, Clinicians, or Hospital Administrators describing the product, problem and the following actions to be taken. The customers were instructed to do the following: 1) Immediately discontinue use of the recalled device. 2) Segregate and quarantine the product subject to recall. 3) Return all affected devices to firm at Argon s expense, using RGA# 28348 to the following mailing address: RGA# 28348, Argon Medical Devices, Inc.,1445 Flat Creek Road Athens, TX 75751 USA, Attn: Arbee Cummings. 4) The recall notice should be shared with anyone who needs to be aware within your organization or to any organization where the potentially affected products have been transferred or further distributed. 5) Complete and return the response form via email to arbee.cummings@argonmedical.com If you need assistance in returning the units, please contact arbee.cummings@argonmedical.com. If you have any questions about this letter, please contact Jorge.Garcia@argonmedical.com or Scott.Bishop@argonmedical.com.
• Quantity in Commerce: 155
• Distribution: US distribution to the states of: TX, WA, CA, IL
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LJS