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U.S. Department of Health and Human Services

Class 2 Device Recall Cordis Aquatrack

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  Class 2 Device Recall Cordis Aquatrack see related information
Date Initiated by Firm August 25, 2009
Date Posted January 13, 2010
Recall Status1 Terminated 3 on August 11, 2010
Recall Number Z-0623-2010
Recall Event ID 53953
510(K)Number K011905  
Product Classification guidewire for use in angiographic procedures - Product Code DQX
Product Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire Diameter .035" Tip Length Flexible 3 cm, Sterile.

Contents 5 Hydrophilic guidewires and torquing devices.
Code Information Lots 80000521 and 80000584
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 Nw 60th Ave
Miami Lakes FL 33014-2802
For Additional Information Contact Hal Baden
786-313-2000
Manufacturer Reason
for Recall		 Some of the guidewires in these two lots have a straight tip (incorrect) rather than an angled tip (correct configuration for that catalog number).
FDA Determined
Cause 2		 Process control
Action Recall for Lot 80000521 was initiated on August 25, 2009 with Cordis Medical Device Recall letters being mailed for delivery on August 25, 2009. Response form was also provided to obtain product disposition. Recall for Lot 80000584 was initiated on October 19, 2009 with Cordis Medical Device Recall letters being mailed for delivery on October 20, 2009. Response form was also provided to obtain product disposition.
Quantity in Commerce 145 units
Distribution Nationwide distribution.
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 = DQX and Original Applicant = MAXXIM MEDICAL
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