Home / Recalls / Cordis Corporation / Z-1826-2017

Z-1826-2017 Class II Terminated

Recalled by Cordis Corporation — Miami Lakes, FL

Recall Details

Product Type
Devices
Report Date
April 26, 2017
Initiation Date
February 16, 2017
Termination Date
August 6, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,700

Product Description

Cordis S.M.A.R.T. Flex Vascular Stent System

Reason for Recall

Deployment Difficulty.

Distribution Pattern

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

Code Information

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

Other recalls by Cordis Corporation

  • Z-0217-2022 Class II — SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indica (October 1, 2021)
  • Z-0221-2022 Class II — SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indic (October 1, 2021)
  • Z-0219-2022 Class II — SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicate (October 1, 2021)
  • Z-0218-2022 Class II — SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indica (October 1, 2021)
  • Z-0220-2022 Class II — SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indica (October 1, 2021)
  • Z-0216-2022 Class II — SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicate (October 1, 2021)
  • Z-2432-2021 Class I — Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C (July 21, 2021)
  • Z-2430-2021 Class I — Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A (July 21, 2021)
  • Z-2431-2021 Class I — Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B (July 21, 2021)
  • Z-2428-2021 Class I — Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, RE (July 21, 2021)