Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
This recall has been terminated (originally issued June 11, 2014).
- Company
- Cordis Corporation
- Recall Initiated
- February 5, 2013
- Posted
- June 11, 2014
- Terminated
- June 23, 2014
- Recall Number
- Z-1784-2014
- Quantity
- 80 units
- Firm Location
- Miami Lakes, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
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.
Lot / Code Info
Catalog # 85R30300S LOT # CE0001447 exp date: 2014-08
Root Cause
Process design
Action Taken
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.