FDA recall Z-0851-2019

Product

Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571

Reason for recall

The products were manufactured with longer than specified sheaths.

Distribution

The products were distributed to the following US states: CA, CT, GA, MA, NY, PA, VA, and WI.

Key facts

Status

Terminated

Initiation date

2018-12-21

Report date

2019-02-27

Termination date

2020-04-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0851-2019