Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Reported: June 18, 2014 Initiated: February 5, 2013 #Z-1784-2014
Product Description
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Reason for Recall
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
Details
- Recalling Firm
- Cordis Corporation
- Units Affected
- 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.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.. Recalled by Cordis Corporation. Units affected: 80 units.
Why was this product recalled? ▼
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 18, 2014. Severity: Moderate. Recall number: Z-1784-2014.
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