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U.S. Department of Health and Human Services

Class 3 Device Recall Percutanious Cathether Introducer Set

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  Class 3 Device Recall Percutanious Cathether Introducer Set see related information
Date Initiated by Firm January 06, 2009
Date Posted February 02, 2010
Recall Status1 Terminated 3 on July 14, 2010
Recall Number Z-0764-2010
Recall Event ID 54172
510(K)Number K780126  
Product Classification Vessel Dilator for Percutaneous Catheterization - Product Code DRE
Product Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number IS-7F07, Disposable, Single Use, Do Not Re-sterilize, Manufactured in USA for VNUS, 5799 Fontanus Way, San Jose CA 95138 USA; General: 408-360-7200.

For catheter exchange or placement of closed end catheters utilizing the Desilets-Hoffman technique.
Code Information Lot 99715418, Exp 2014-05.
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		 One lot of Percutaneous Catheter Introducer Set contained incorrect size needle.
FDA Determined
Cause 2		 Other
Action Firm notified sole consignee by an Urgent Medical Device Recall certified letter dated 1/6/2010. The letter identified the product being recalled and asked the consignee to immediately quarantine any product remaining at their facility. The recall should be conducted to the user level. Affected products at the consignee's facility and with their customers, should be returned using the instructions on the response form. The response forms are to completed and returned by fax or e-mail as indicated. Questions or the need for additional information concerning this recall should be directed to Sarah Larson at 903-677-9351 or Sarah.Larson@argonmedical.com.
Quantity in Commerce 500 units
Distribution Nationwide Distribution -- State of CA.
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 = DRE and Original Applicant = ARGON MEDICAL CORP.
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