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U.S. Department of Health and Human Services

Class 2 Device Recall MassTRANSIT Infusion Catheter Kit

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  Class 2 Device Recall MassTRANSIT Infusion Catheter Kit see related information
Date Initiated by Firm June 30, 2008
Date Posted December 30, 2008
Recall Status1 Terminated 3 on January 02, 2009
Recall Number Z-0604-2009
Recall Event ID 50154
510(K)Number K983003  
Product Classification Continuous Flush Catheter - Product Code KRA
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.
Code Information Lot Number 13358689 and 13350390.
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 Nw 60th Ave
Miami Lakes FL 33014-2802
For Additional Information Contact
786-313-2000
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KRA and Original Applicant = CORDIS NEUROVASCULAR, INC.
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