Home / Recalls / Cordis Corporation / Z-0003-2014

Z-0003-2014 Class II Terminated

Recalled by Cordis Corporation — Miami Lakes, FL

FDA device recall Z-0003-2014 was initiated by Cordis Corporation on Aug 12, 2013 and is designated Class II. Reason for recall: Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension. The recall status is terminated (terminated Sep 30, 2014). Affected quantity: 1238 units.

Recall Details

Product Type: Devices
Report Date: Oct 9, 2013
Initiation Date: Aug 12, 2013
Termination Date: Sep 30, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1238 units

Product Description

Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.

Reason for Recall

Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension.

Distribution Pattern

Worldwide Distribution - USA Nationwide in the states of AZ, CA, FL, ID, LA, MA, MD, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TX, VA, WI, and WV and the countries of: Austria, Belgium, Czech Republic, France, Germany, Greece,Hungary, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, United Arab, and United Kingdom

Code Information

Catalog Lots ---------------------------------- 67200000 15918614 67200200 15892736 67200400 15892737, 15897416 67200500 15901314 67203400 15922021 67203600 15897418 67204000 15925687 67205200 15892738, 15892739 67205400 15885645, 15887472, 15897420 67205600 15901319 67206000 15897422 67207200 15892740 67208000 15892741 67208200 15887473, 15887474, 15897424 67208300 15901321 67212600 15916942 67213000 15916943 67227000 15901323

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0003-2014
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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… (Oct 1, 2021)
Z-0216-2022 Class II — SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is… (Oct 1, 2021)
Z-0221-2022 Class II — SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is… (Oct 1, 2021)
Z-0218-2022 Class II — SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is… (Oct 1, 2021)
Z-0219-2022 Class II — SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is… (Oct 1, 2021)
Z-0220-2022 Class II — SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is… (Oct 1, 2021)
Z-2432-2021 Class I — Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C (Jul 21, 2021)
Z-2428-2021 Class I — Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter… (Jul 21, 2021)
Z-2429-2021 Class I — Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB (Jul 21, 2021)
Z-2431-2021 Class I — Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B (Jul 21, 2021)