Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Varilase

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Varilase see related information
Date Initiated by Firm October 09, 2003
Date Posted November 06, 2003
Recall Status1 Terminated 3 on November 21, 2005
Recall Number Z-0101-04
Recall Event ID 27557
510(K)Number K030654  
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product Vari-Lase Endovenous Laser Procedural Kit, Model 7000
Code Information Lot numbers S000102, 300537, and 300536.
Recalling Firm/
Manufacturer		 Vascular Solutions, Inc
2495 Xenium Ln N
Minneapolis MN 55441-3625
For Additional Information Contact Brad Andersen
763-656-4307
Manufacturer Reason
for Recall		 An internal gasket of the Fiber Lock component of the Vari-Lase Kit contains natural rubber latex, but the product labeling does not recognize the presence of latex and include the required cautionary statement.
FDA Determined
Cause 2		 Other
Action Letters dated October 9, 2003 were sent to the consignees. The letters instruct the consignees to place the enclosed warning stickers, about latex in the product, on the boxes and pouches of any remaining product in inventory at the consignees. After completing the relabeling, consignees are to fill out the attached form and fax it to the firm to document the field correction.
Quantity in Commerce 390 kits
Distribution The product was distributed nationwide in the United States and to Romania.
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 = GEX and Original Applicant = VASCULAR SOLUTIONS, INC.
-
-