Cook Inc.: Medical Device Recall in 2019 - (Recall #: Z-0851-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 21, 2018

Date Posted: February 27, 2019

Recall Number: Z-0851-2019

Event ID: 82007

Reason for Recall:

The products were manufactured with longer than specified sheaths.

Status: Terminated

Product Quantity: 24

Code Information:

lot 8858425

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated