FDA Recall
Terminated
VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138
Recall: Z-0542-2008
·
Initiated August 8, 2007
Recall
- Recall Number
- Z-0542-2008
- Event Number
- 45510
- Firm
- VNUS Medical Technologies Inc
- FEI Number
- 3001236355
- Product Code
- GEI
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- August 8, 2007
- Posted
- January 24, 2008
- Terminated
- May 22, 2008
- Address
- 5799 Fontanoso Way, San Jose, CA, 95138-1015
Description
VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138
Reason
Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation.
Action
The Recalling firm is updating the Instructions For Use, training materials, and procedural guides to incorporate the treatment recommendations. The recalling firm sent an Update to customers who received the product, Important Update Regarding the Use of the VNUS ClosureFAST Catheter, dated August 6, 2007 with supplemental device instructions. Future product distribution will include the updated labeling.
Distribution
Worldwide
Quantity
16,716 units