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Terminated

VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138

FDA Recall Z-0132-2008 · Posted 2007-12-15

Recalling FirmVNUS Medical Technologies Inc
Recall StatusTerminated
Product CodeGEI
Date Initiated2007-03-06
Date Terminated2007-12-17
Product Quantity92 units

Reason for Recall

Sterility (package integrity) Compromised: Product sterility may be compromised due to a pinhole under the pouch foldover.

Firm Action

The recalling firm has issued customer notification letters by mail on 03/06/2007. The firm is requesting that consignees discontinue their use of the device and return recalled product . The firm will provide replacements.

Root Cause

Package design/selection

Distribution Pattern

Nationwide: Product was distributed to 18 health care providers and medical centers throughout the US in the following states: TX, UT, CA, CT, MI, NY, MI, OR, WA, VA, PA, and NJ.

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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