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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KRA
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