Recall Z-1198-2019 ยท DQY Catheter, Percutaneous
Cordis Corporation
Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
| Date | Feb 7, 2019 |
| Status | Terminated |
| Reason | Frayed pieces of the mounting card being inside the primary packaging. |
| Root cause | Equipment maintenance |
| Action | A letter and Acknowledgement Form will be sent overnight on February 07, 2019 to the direct consignees. The letter provides instructions to our direct consignees to notify any additional consignees or departments as to the market action. For health care professionals with medical concerns, please contact the Cordis Endovascular Medical Information Line 877-DEVICE5 (877-338-4235, Monday through Friday from 9:00 AM to 5:00 PM EST. For questions related to the recall and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: GMB-Fiel |
| Quantity | 23481 |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and Guam Singapore and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021593 | MODIFICATION TO ENVOY AND VISTA BRITE TIP Cordis Corp., Jun 13, 2002 |
| K143412 | ADROIT Guiding Catheter Cordis Corporation, Jan 14, 2015 |
| K963962 | VISTA BRITE TIP CATHETERS Cordis Corp., May 7, 1997 |
| K972978 | VISTA BRITE TIP GUIDING CATHETERS Cordis Corp., Oct 21, 1997 |
| K992673 | VISTA BRITE TIP CATHETERS Cordis Corp., Oct 12, 1999 |