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.

Reason: The incorrect outer carton box was used for the product.

Code information: AngioSculpt PTCA lot #G18090030.

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