VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length), Manufactured by VNUS Medical Technologies, Inc
FDA device recall Z-0543-2008 · posted 2008-01-24 · Terminated
Recall details
- Recalling firm
- VNUS Medical Technologies Inc
- Reason for recall
- Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation.
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 6,221 units
- Distribution
- Worldwide
- Date initiated
- 2007-08-08
- Date posted
- 2008-01-24
- Date terminated
- 2008-05-22
- Location
- San Jose, CA
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