Recall Z-0101-04 ยท GEX Powered Laser Surgical Instrument
Vascular Solutions, Inc
Vari-Lase Endovenous Laser Procedural Kit, Model 7000
| Date | Nov 6, 2003 (initiated Oct 9, 2003) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 390 kits |
| Distribution | The product was distributed nationwide in the United States and to Romania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030654 | VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT Vascular Solutions, Inc., Jun 18, 2003 |