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U.S. Department of Health and Human Services

Class 2 Device Recall Cordis EMPIRA RX PTCA Dilatation Catheter

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 Class 2 Device Recall Cordis EMPIRA RX PTCA Dilatation Cathetersee related information
Date Initiated by FirmFebruary 05, 2013
Date PostedJune 11, 2014
Recall Status1 Terminated 3 on June 23, 2014
Recall NumberZ-1784-2014
Recall Event ID 64273
510(K)NumberK110133 
Product Classification cardiovascular dilitation catheter - Product Code LOX
ProductCordis 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
For Additional Information Contact
786-313-2000
Manufacturer Reason
for Recall		Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
FDA Determined
Cause 2		Process design
ActionAn 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 Commerce80 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = LOX
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