Reported Aug 18, 2021 · Terminated
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
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 SABER PTA Balloon Dilation Catheter4FREF 48004010X
- Lot codes and dates
- Lot/Batch number 82219442
- Amount recalled
- 8 units
Where it was sold
Why it was recalled
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
This product could cause temporary or reversible health problems — stop using it.
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