FDA recall Z-1376-2019

Product

Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20

Reason for recall

There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.

Distribution

The products were distributed US nationwide. The products were distributed to the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.

Key facts

Status

Terminated

Initiation date

2019-04-26

Report date

2019-06-05

Termination date

2020-09-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Elkton, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1376-2019