Recall Z-0543-2008 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
VNUS Medical Technologies Inc
VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138
| Date | Jan 24, 2008 (initiated Aug 8, 2007) |
| Status | Terminated |
| Reason | Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation. |
| Root cause | Labeling design |
| 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. |
| Quantity | 6,221 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.