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Class 2 Device Recall Cordis EMPIRA RX PTCA Dilatation Catheter |
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Date Initiated by Firm |
February 05, 2013 |
Date Posted |
June 11, 2014 |
Recall Status1 |
Terminated 3 on June 23, 2014 |
Recall Number |
Z-1784-2014 |
Recall Event ID |
64273 |
510(K)Number |
K110133
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Product Classification |
cardiovascular dilitation catheter - Product Code LOX
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Product |
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use. |
Code Information |
Catalog # 85R30300S LOT # CE0001447 exp date: 2014-08 |
Recalling Firm/ Manufacturer |
Cordis Corporation 14201 Nw 60th Ave Miami Lakes FL 33014-2802
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For Additional Information Contact |
786-313-2000
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Manufacturer Reason for Recall |
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
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FDA Determined Cause 2 |
Process design |
Action |
An Urgent Medical Device Recall letter and Acknowledgement form was sent overnight to mulitple contacts in each account February 7, 2013. A representative will follow-up as necassary to facility obtaining signature, faxing the acknowledgment form to Cordis, collecting and returning units. |
Quantity in Commerce |
80 units |
Distribution |
Worldwide distribution: US states: AZ, FL, IL, LA, MA, NJ, OR, SC, and TX. Armenia, Austria, Belgium, Colombia, Czech Republic, France, Hungary, Iran, Israel, India, Italy, Kuwait, Latvia, Lebanon, Luxembourg, Mexico, Morocco, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Switzerland, and United Arab Emirates. |
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 = LOX and Original Applicant = CREGANNA-TACTX MEDICAL
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