Home / Recalls / Cordis Corporation / Z-2235-2021

Z-2235-2021 Class II Terminated

Recalled by Cordis Corporation — Miami Lakes, FL

Recall Details

Product Type: Devices
Report Date: August 18, 2021
Initiation Date: July 19, 2021
Termination Date: February 16, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8 units

Product Description

Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X

Reason for Recall

The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.

Code Information

Lot/Batch number 82219442

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-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-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-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-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-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)