FDAFDA · Food and drugs·Recall number Z-1784-2014
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Published June 18, 2014 · Recall initiated: February 5, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Cordis Corporation
- Distributor
- 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.
- Lot
- Catalog # 85R30300S LOT # CE0001447 exp date: 2014-08
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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