Vari-Lase Endovenous Laser Procedural Kit, Model 7000
FDA Recall Z-0101-04 · Posted 2003-11-06
Recalling FirmVascular Solutions, Inc
Recall StatusTerminated
Product CodeGEX
Date Initiated2003-10-09
Date Terminated2005-11-21
Product Quantity390 kits
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.
Firm 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.
Root Cause
Other
Distribution Pattern
The product was distributed nationwide in the United States and to Romania.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.