Cook Inc.: Medical Device Recall in 2016 - (Recall #: Z-0865-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices

Product Classification:

Class II

Date Initiated: January 20, 2016

Date Posted: March 2, 2016

Recall Number: Z-0865-2016

Event ID: 73163

Reason for Recall:

Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.

Status: Terminated

Product Quantity: 25

Code Information:

Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Lot: 6166304

Distribution Pattern:

Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.

Voluntary or Mandated:

Voluntary: Firm initiated