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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

Product Description Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Recall Number Z-1784-2014
Classification Class II
Code Info Catalog # 85R30300S LOT # CE0001447 exp date: 2014-08
Product Distributed Qty 80 units
Reason For Recall Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.

Event Detail

Event Id 64273
Product Type Devices
Status Ongoing
Recalling Firm Cordis Corporation
City Miami Lakes
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-05
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern 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.