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U.S. Department of Health and Human Services

Class 2 Device Recall CATHETER INTRODUCER KIT

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  Class 2 Device Recall CATHETER INTRODUCER KIT see related information
Date Initiated by Firm March 29, 2010
Date Posted June 02, 2010
Recall Status1 Terminated 3 on July 29, 2010
Recall Number Z-1739-2010
Recall Event ID 55234
510(K)Number K781333  
Product Classification Tube, gastro-enterostomy - Product Code KGC
Product CATHETER INTRODUCER KIT SPECIAL RIGHT HEART KIT REF/REORDER NO. 496413Y. Disposable Single Use, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
Code Information Catalog Number: 496413Y, Lot Number: 99737884, Expiration Date: 2014-06.
Recalling Firm/
Manufacturer		 Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751
For Additional Information Contact Andrea Wieczor
903-677-9375
Manufacturer Reason
for Recall		 There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
FDA Determined
Cause 2		 Package design/selection
Action Argon Medical Devices issued an "Urgent Medical Device Recall" notification via certified mail dated March 29, 2010 to distributors and end users. A Response Form was attached. Consignees were informed of the affected product and asked to quarantine and return all unused product to the firm. For further information, contact Argon Medical Devices at 1-903-677-9375.
Quantity in Commerce 70 kits
Distribution Distributed to United States (IL, AL, NY, TX, OK, MI, NC, CA, OH, VA, KY, CO, LA, WA, MO, AND IA) and Canada.
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 = KGC and Original Applicant = ARGON MEDICAL CORP.
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