Spectranetics Corporation recalls Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-25…

Recall date

December 7, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0576-2020

FDA classification

Class II

Brand / firm

Spectranetics Corporation

Sold / distributed

Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution.

Why it was recalled

The incorrect outer carton box was used for the product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.