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Crédits
Devices
Device Recall Cordis S.M.A.R.T. Flex Vascular Stent System
Modèle / numéro de série
1.) Catalog Numbers SF05200MV, Size 5 x 200mm, Catheter length 120 cm GTIN -Carton Level 20705032066829 Lot #'s: 34551, 34552, 34585, 34586, 34587, 35009, 35199, 35228, 35706, 35741, 35859, 35860, 36160, 36275, 36380, 36666, 36792, 36859, 36902, 36903, 37007, 37091, 37155, 37349, 37350, 37350, 37961, 37962, 38059, 38315, 38515, 38529, 38529, 38628, 38629, 39001, 39002, 39195, 39398, 39427, 39644, 39862, and 39974 2.) Catalog Numbers SF05200SV, Size 5 x 200mm, Catheter length 80 cm GTIN -Carton Level 20705032066409 Lots #'s: 35707, 35742, 35965, 36161, 36667, 36793, 37351, 37963, 39158, 39351, 39352, 39554, 39641, and 39863 3.) Catalog Numbers SF06200MV, Size 6 x 200mm, Catheter length 120 cm GTIN -Carton Level 20705032066836 Lots #'s: 34469, 34470, 34588, 34589, 34823, 3487534993, 35006, 35068, 35069, 35229, 35287, 35352, 35469, 35470, 35715, 35755, 35823, 35868, 35945, 35971, 36032, 36033, 36163, 36279, 36322, 36388, 36537, 36678, 36742, 36804, 36865, 37019, 37106, 37168, 37250, 37352, 37707, 37975, 38063, 38282, 38319, 38429, 38513, 38569, 38747, 38850, 38921, 39007, 39162, 39200, 39267, 39358, 39405, 39949, and 39955 and 4.) Catalog Numbers SF06200SV Size 5 x 200mm, Catheter length 80 cm GTIN -Carton Level 20705032067024 Lots #'s 35077, 35165, 35361, 35500, 35568, 35597, 35716, 35756, 35824, 35946, 35972, 36034, 36164, 36538, 36679, 36680, 36805, 37107, 37169, 37541, 37579, 37708, 38064, 38167, 38168, 38320, 38321, 38530, 38748, 39201, 39439, 39440, 39645, 39646, 39959, and 39971 ALL UNEXPIRED LOTS NUMBERS
Classification du dispositif
Cardiovascular Devices
Classe de dispositif
3
Dispositif implanté ?
Yes
Distribution
FOREIGN ONLY: ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY, IRAN, ISRAEL, ITALY, JORDAN, KOREA (South), KUWAIT, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, POLAND, PORTUGAL, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, and UNITED KINGDOM
Description du dispositif
Cordis S.M.A.R.T. Flex Vascular Stent System
Manufacturer
Cordis Corporation
1 Event
Rappel de Device Recall Cordis S.M.A.R.T. Flex Vascular Stent System
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Fabricant
Cordis Corporation
Adresse du fabricant
Cordis Corporation, 14201 NW 60th Ave, Miami Lakes FL 33014-2802
Société-mère du fabricant (2017)
Cardinal Health
Source
USFDA
Language
English
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