Vari-Lase Endovenous Laser Procedural Kit, Model 7000
FDA device recall Z-0101-04 · posted 2003-11-06 · Terminated
Recall details
- Recalling firm
- Vascular Solutions, Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 390 kits
- Distribution
- The product was distributed nationwide in the United States and to Romania.
- Date initiated
- 2003-10-09
- Date posted
- 2003-11-06
- Date terminated
- 2005-11-21
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT (K030654) | Vascular Solutions, Inc. | 2003-06-18 |