Vari-Lase Endovenous Laser Procedural Kit, Model 7000
Hazard
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.
What You Should Do
Remedy
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.
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Products
Vari-Lase Endovenous Laser Procedural Kit, Model 7000
- Brand
- Vascular Solutions, Inc
- UPC
- Lot numbers S000102, 300537, and 300536.
Units Affected
390 kits