FDA recall Z-0576-2020

Product

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 for recall

The incorrect outer carton box was used for the product.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-12-07

Report date

2019-12-04

Termination date

2020-10-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0576-2020