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U.S. Department of Health and Human Services

Class 2 Device Recall EMPIRA (TM) NC RX PTCA Dilatation Catheter

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  Class 2 Device Recall EMPIRA (TM) NC RX PTCA Dilatation Catheter see related information
Date Initiated by Firm June 23, 2014
Date Posted August 28, 2014
Recall Status1 Terminated 3 on December 14, 2016
Recall Number Z-2556-2014
Recall Event ID 68834
510(K)Number K110133  
Product Classification Catheters, transluminal coronary angioplasty, percutaneous - Product Code LOX
Product Cordis EMPIRA NC RX PTCA Dilatation Catheter
Code Information 63 Catalog numbers:  75R06200N, 75R06225N, 75R06250N, 75R06275N, 75R06300N, 75R06325N, 75R06350N, 75R06375N, 75R06400N, 75R10200N, 75R10225N, 75R10250N, 75R10275N, 75R10300N, 75R10325N, 75R10350N, 75R10375N, 75R10400N, 75R12200N, 75R12225N, 75R12250N, 75R12275N, 75R12300N, 75R12325N, 75R12350N, 75R12375N, 75R12400N, 75R15200N, 75R15225N, 75R15250N, 75R15275N, 75R15300N, 75R15325N, 75R15350N, 75R15375N, 75R15400N, 75R20200N, 75R20225N, 75R20250N, 75R20275N, 75R20300N, 75R20325N, 75R20350N, 75R20375N, 75R20400N, 75R25200N, 75R25225N, 75R25250N, 75R25275N, 75R25300N, 75R25325N, 75R25350N, 75R25375N, 75R25400N, 75R25200N, 75R25225N, 75R25250N, 75R25275N, 75R25300N, 75R25325N, 75R25350N, 75R25375N, and 75R25400N.
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 Nw 60th Ave
Miami Lakes FL 33014-2802
For Additional Information Contact Hal Baden
786-313-2365
Manufacturer Reason
for Recall		 The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.
FDA Determined
Cause 2		 Environmental control
Action Cordis Corp sent Urgent Medical Device Correction Letters dated June 23, 2014, to all affected customers. Those in the Foreign Countries were sent via E-mail dated June 23, 2014. The letter identified the product the problem and the action needed to be taken by the customer. Cordis and Creganna-Tactx are not removing the products, but rather providing additional labeling (customer letter) advising the user not to use the product if unusual resistance is felt during removal of the balloon cover. Cordis and Creganna-Tactx explained in the letter to the consignees that is is known that balloons with hydrophilic coating are susceptible to expansion of the coating at extremely elevated humidity, therefore, it is important for the User to follow the current labeling, to store the product in a cool, dark and dry place. Action requested on your part: "Pass on this letter to anyone who needs to be informed in your facility and in any facility where potentially affected devices may have been transferred. "Maintain awareness of this communication until the information has been incorporated into the Cordis EMPIRA" NC RX and EMPIRA" RX PTCA dilatation catheter labeling. "Retain this letter with affected product. "Report all balloon cover removal difficulties through the standard complaint process. "For questions related to the issue please contact Cordis Endovascular Medical information Line 877-DEVICE5 (877-338-4235), Monday through Friday from 9:00AM to 5:00 PM EDT. "For questions related to the Acknowledgment Form and its return, please contact Cordis QA at (786) 313-8730.
Quantity in Commerce 250,000 units
Distribution Worldwide Distribution - USA including Puerto Rico and the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WY and Hawaii., and the countries of Argentina, Brazil, Canada, Chile, Colombia, Mexico, Panama and Venezuela.
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 = LOX and Original Applicant = CREGANNA-TACTX MEDICAL
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