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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

FDA Recall Z-0542-2008 · Posted 2008-01-24

Recalling FirmVNUS Medical Technologies Inc
Recall StatusTerminated
Product CodeGEI
Date Initiated2007-08-08
Date Terminated2008-05-22
Product Quantity16,716 units

Reason for Recall

Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation.

Firm 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.

Root Cause

Labeling design

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061373VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100Vnus Medical Technologies, Inc. · 2006-08-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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