FDA recall Z-3055-2020

Product

Pacific Xtreme (PTCA Balloon Dilation Catheter)

Reason for recall

Labeling discrepancy for the Rated Burst Pressure (RBP) value.

Distribution

Domestic Distribution: AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL,IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX,VA, WA, WI and WV. International Distribution: Canada and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2020-08-26

Report date

2020-10-07

Termination date

2023-06-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3055-2020