Recall Z-0003-2014 ยท DQY Catheter, Percutaneous
Cordis Corporation
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
| Date | Oct 1, 2013 (initiated Aug 12, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Error in labeling |
| Action | Cordis sent an Urgent Medical Device Recall letter dated August 12, 2013 Acknowledgement Form to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to immediately identify and set aside all affected product in a manner that ensures the product will not be used. Customers were asked to review, complete, sign and return the enclosed Acknowledgement form directly to Cordis to the fax number on the form. For questions call the Customer Service number at 800-561-7683. |
| Quantity | 1238 units |
| Distribution | 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 Feder |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131225 | ADROIT GUIDING CATHETER Cordis Corp., A Johnson & Johnson Co., May 29, 2013 |