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VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm… recallZ-0542-2008 · VNUS Medical Technologies Inc · initiated Aug 8, 2007

Terminated All recalls posted in January 2008

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

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

FDA root cause category: Labeling design

What the company is doing

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.

Recall details

Recall number
Z-0542-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 8, 2007
Posted by the FDA
Jan 24, 2008
Recalling firm
VNUS Medical Technologies Inc
Quantity
16,716 units
Product code
GEI
FDA submissions
K061373
Distribution
Worldwide

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Lot #s:  319484,  274119,  274900,  275146,  275637,  276054,  277311,  277775,  278742,  279181,  279614,  279880,  279938,  280314,  280315,  280316,  285851,  286800,  287108,  287566,  288293,  292135,  292432,  293002,  293275,  293276,  293830,  293832,  294657,  294881,  294882,  295263,  296973,  298603,  299607,  299929,  300573,  301032,  301354,  302329,  302628,  303250,  303712,  303723,  304640,  304698,  305533,  305894,  306571,  306834,  307366,  307561,  307938,  307951,  308465,  309081,  309441,  309741,  309782,  310338,  310401,  310408,  310920,  311185,  312220,  312241,  312334,  313084,  313104,  313373,  313530,  313792,  314079,  314241,  314548,  314655,  315253,  315389,  315751,  315765,  315913,  315922,  316405,  316652,  316653,  316947,  317041,  317342,  317421,  318802,  319117, and  319253

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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