Home / Recalls / Cordis Corporation / Z-0216-2022

Z-0216-2022 Class II Ongoing

Recalled by Cordis Corporation — Miami Lakes, FL

Recall Details

Product Type
Devices
Report Date
November 24, 2021
Initiation Date
October 1, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9 units

Product Description

SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

Reason for Recall

There is a potential for distal tip dislodgement or separation.

Distribution Pattern

US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.

Code Information

Product Code: SF09060SB; Lot No. 253349

Other recalls by Cordis Corporation

  • 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-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-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-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-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-2430-2021 Class I — Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A (July 21, 2021)
  • Z-2432-2021 Class I — Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C (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)
  • Z-2429-2021 Class I — Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB (July 21, 2021)