medical Class II Updated 2021-08-18

Cordis Corporation recalls Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010

Recalled Product

Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot/Batch number 82219442
View official government recall

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