FDA Recall Terminated

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.

Recall: Z-0604-2009 · Initiated June 30, 2008

Recall

Recall Number: Z-0604-2009
Event Number: 50154
Firm: Cordis Corporation
FEI Number: 1016427
Product Code: KRA
Status: Terminated
Root Cause: Pending
Initiated: June 30, 2008
Posted: December 30, 2008
Terminated: January 2, 2009
Address: 14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802

Description

Reason

Two lots of Cordis Neurovascular Masstransit Infusion Catheter Kits has the potential for sterile PTFE contamination within the inner lumen of the catheter.

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, the facility should be contacted to arrange return of the product. If there are any additional questions, Customer Service may be also be contacted at 800-551-7683.

Distribution

Nationwide Distribution --- including states of Colorado, Connecticut, Florida, Minnesota, Nebraska, Nevada, Ohio, Oregon, and Virginia.

Quantity