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Medical Device Recalls
Class 2 Recall
VNUS 7F ClosureFAST Catheter
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Date Recall
Initiated |
August 08, 2007
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| Date Posted |
January 24, 2008
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| Recall Number |
Z-0542-2008
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| Product |
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
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| Code Information |
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
|
Recalling Firm/
Manufacturer |
VNUS Medical Technologies Inc
5799 Fontanoso Way
San Jose
, California
95138-1015
|
Reason For
Recall |
Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation.
|
| 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.
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| Quantity in Commerce |
16,716 units
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| Distribution |
Worldwide
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