Z-0604-2009

MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular Intended to be used as a...

Name: Z-0604-2009 MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular Intended to be used as a...
Creator: Cordis Corporation
Published: 2008-06-30
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2008-06-30 / Terminated / root cause: sterility

FDA source

Cordis Corporation began a recall of MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular Intended to be used as a mechanism for the infusion of various diagnostic... on 2008-06-30. The reason FDA records is "Two lots of Cordis Neurovascular Masstransit Infusion Catheter Kits has the potential for sterile PTFE contamination within the inner lumen of the catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0604-2009
Status: Terminated
Initiated: 2008-06-30
Posted: 2008-12-30
Terminated: 2009-01-02
Recalling firm: Cordis US Corp.
Product: 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.
Product code: KRA Catheter, Continuous Flush
Reason for recall: 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 tag: sterility
FDA 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, 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.
Quantity in commerce: 27
Distribution: Nationwide Distribution --- including states of Colorado, Connecticut, Florida, Minnesota, Nebraska, Nevada, Ohio, Oregon, and Virginia.
Product codes and lots: Lot Number 13358689 and 13350390.

Product code KRA

K983003Class II1 Mass Transit Infusion Catheter, 1 VariousCordis Neurovascular, Inc. / cleared 1998-09-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)