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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-1482-06
Recall Event ID 36077
510(K)Number K021591  
Product Classification Continuous Flush Catheter - Product Code KRA
Product Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.
Code Information All lot numbers equal to or lower than: CAT 606051FX - LOT 13084977; CAT 606051JX - LOT 13077739; CAT 606051MX - LOT 13100828; CAT 606151FX - LOT 13095822; CAT 606151JX - LOT 13090978; CAT 606151MX - LOT 13090976; CAT 6062310F - LOT 13090973; CAT 6062310J - LOT 13090974; CAT 6062310M - LOT 13082015; CAT 6062510FX - LOT 13075472; CAT 6062510JX - LOT 13090975; CAT 6062510MX - LOT 13082020; CAT 6062511FX - LOT 13090979; CAT 6062511JX - LOT 13090971; CAT 6062511MX - LOT 13090972.
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 15 Lot numbers (46,452)
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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