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VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS… recallZ-0132-2008 · VNUS Medical Technologies Inc · initiated Mar 6, 2007

Terminated All recalls posted in December 2007

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from VNUS Medical Technologies Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Package design/selection

What the company is doing

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.

Recall details

Recall number
Z-0132-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 6, 2007
Posted by the FDA
Dec 15, 2007
Recalling firm
VNUS Medical Technologies Inc
Quantity
92 units
Product code
GEI
FDA submissions
K061373
Distribution
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.

Product description

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

Code information (models, lots, serial numbers)

Lot Numbers: 269431 and 269157

Other devices under the same FDA submission

4 devices cleared under K061373 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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