Reported Jun 18, 2014 · Terminated
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Cordis Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cordis Corporation · 14201 Nw 60th Ave · Miami Lakes, FL · 33014-2802
Is this the product you have?
- Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
- Lot codes and dates
- Catalog # 85R30300S LOT #
- CE0001447 exp date2014-08
- Amount recalled
- 80 units
Where it was sold
Why it was recalled
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
This product could cause temporary or reversible health problems — stop using it.
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