Class 2 Device Recall Argon Medical Devices Catheter Introducer Kit, PCI Kit with Feather Dilator Pediatric, 6F

• Date Initiated by Firm: March 14, 2011
• Date Posted: April 27, 2011
• Recall Status: Terminated on April 24, 2012
• Recall Number: Z-2085-2011
• Recall Event ID: 58289
• Product Classification: kit, plastic surgery and accessories - Product Code FTN
• Product: Argon Medical Devices Catheter Introducer Kit, PCI Kit with Feather Dilator - Pediatric, 6F, Part Number 496310, Lot Number 99767643 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous introduction of catheters.
• Code Information: Lot number 99767643
• Recalling Firm/ Manufacturer: Argon Medical Devices, Inc; 1445 Flat Creek Rd; Athens TX 75751
• For Additional Information Contact: 903-675-9321
• Manufacturer Reason for Recall: Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
• FDA Determined Cause: Other
• Action: Argon Medical Devices sent an Urgent Medical Device Recall letter dated March 14, 2011, by certified mail to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify, quarantine and return any product remaining at their facility utilizing the instruction on the 2011 Tray Recall Response Form. Customers were instructed to complete the response form included with the letter and return by fax or email as indicated as soon as possible. Customers were instructed to pass the notice on to all those who need to be aware within their organization or to any organization where the potentially affected devices have been transferred. For questions regarding this recall call (903) 677-9375.
• Quantity in Commerce: 50 units
• Distribution: Worldwide Distribution - USA including AL, AZ, CA, CO, DE, GA, HI, IL, IN, LA, MD, MN, ND, NE, NH, NJ, NY, OK, PA, SC, TX, VA, WA, and WI and the countries of Nationwide, Japan, Australia, Canada, Singapore, and the Netherlands
• 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.