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U.S. Department of Health and Human Services

Class 2 Device Recall Cordis Continuous Flush Catheter

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  Class 2 Device Recall Cordis Continuous Flush Catheter see related information
Date Initiated by Firm August 11, 2006
Date Posted September 02, 2006
Recall Status1 Terminated 3 on November 25, 2008
Recall Number Z-1483-06
Recall Event ID 36077
510(K)Number K021591  
Product Classification Continuous Flush Catheter - Product Code KRA
Product Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters.
Code Information All lot numbers equal to or lower than: CAT 606S152FX - LOT 13009595; CAT 606S152JX - LOT 13010913; CAT 606S152MX - LOT 13009596; CAT 606S155FX - LOT 13082017; CAT 606S155JX - LOT 13078245; CAT 606S155MX - LOT 13082016; CAT 606S252FX - LOT 13064387; CAT 606S252JX - LOT 13071036; CAT 606S252MX - LOT 13090990; CAT 606S255FX - LOT 13084973; CAT 606S255JX - LOT 13084974; CAT 606S255MX - LOT 13064409
Recalling Firm/
Manufacturer		 Cordis Neurovascular, Inc.
14200 NW 57th Ct
Miami Lakes FL 33014-3105
Manufacturer Reason
for Recall		 Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a pinhole or tear in the Mylar pouch, which may result in a compromise of the sterility inside the pouch.
FDA Determined
Cause 2		 Other
Action All consignees were notified by letter on 8/14/06. All Cordis Neurovascular sales representatives will also participate, to ensure expedited communication.
Quantity in Commerce 12 Lot numbers (14,161)
Distribution Class II Recall - Worldwide distribution --- including USA and countries of Asia Pacific, Europe, Latin America, Canada, Japan and Australia.
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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