Cordis S.M.A.R.T. Flex Vascular Stent System
This recall has been terminated (originally issued February 16, 2017).
- Company
- Cordis Corporation
- Recall Initiated
- February 16, 2017
- Terminated
- August 6, 2019
- Recall Number
- Z-1826-2017
- Quantity
- 2,700
- Firm Location
- Miami Lakes, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Deployment Difficulty.
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
Lot / Code Info
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
Root Cause
Other
Action Taken
Email to the Cardinal Health and J&J country entities sent February 16, 2017. Each country will perform the recall locally. (This is an OUS only Removal.)