Home / Recalls / Cordis Corporation / Z-1477-2020

Z-1477-2020 Class II Terminated

Recalled by Cordis Corporation — Miami Lakes, FL

Recall Details

Product Type
Devices
Report Date
March 18, 2020
Initiation Date
January 8, 2020
Termination Date
January 13, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
89 units

Product Description

Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S

Reason for Recall

Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.

Distribution Pattern

US and UK

Code Information

Lot 82155955, Use by date 2021-06-30

Other recalls by Cordis Corporation

  • 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-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-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-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-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-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)