Recall Z-0604-2009 ยท KRA Catheter, Continuous Flush
Cordis Corporation
MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular Intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the Neurovascular, Peripheral Vascular and Coronary Vascular systems and for superselective angiography of peripheral and coronary vasculature.
| Date | Dec 30, 2008 (initiated Jun 30, 2008) |
| Status | Terminated |
| Reason | Two lots of Cordis Neurovascular Masstransit Infusion Catheter Kits has the potential for sterile PTFE contamination within the inner lumen of the catheter. |
| Root cause | Pending |
| Action | A Medical Device Recall letter, dated 6/30/2008, and Acknowledgement Form were sent overnight. The firm asked customers to set aside any affected product in a manner that ensures it will not be used. Customers are asked to review, sign and return the enclosed Acknowledgement Form directly to Cordis Neurovascular. Customers can either return any product with reference to the RA# on the form, or contact their local sales reps to facilitate return of the affected product. Customers will receive a credit for the units they return. If any affected product has been forwarded to another facility |
| Quantity | 27 |
| Distribution | Nationwide Distribution --- including states of Colorado, Connecticut, Florida, Minnesota, Nebraska, Nevada, Ohio, Oregon, and Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983003 | 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS Cordis Neurovascular, Inc., Sep 17, 1998 |