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U.S. Department of Health and Human Services

Class 2 Device Recall Argon Medical Devices Catheter Introducer Kit, PCI Kit with Feather Dilator Pediatric, 7F,

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  Class 2 Device Recall Argon Medical Devices Catheter Introducer Kit, PCI Kit with Feather Dilator Pediatric, 7F, see related information
Date Initiated by Firm March 14, 2011
Date Posted April 27, 2011
Recall Status1 Terminated 3 on April 24, 2012
Recall Number Z-2086-2011
Recall Event ID 58289
Product Classification kit, plastic surgery and accessories - Product Code FTN
Product Part Number 496311, Lot Number 99768100

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 99768100
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 2		 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 60 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.
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