Cook Inc.: Medical Device Recall in 2021 - (Recall #: Z-0185-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.

Product Classification:

Class II

Date Initiated: September 28, 2021

Date Posted: November 10, 2021

Recall Number: Z-0185-2022

Event ID: 88787

Reason for Recall:

Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time.

Status: Terminated

Product Quantity: 48 (OUS)

Code Information:

lot 13861362

Distribution Pattern:

Domestic distribution to AR AZ CT FL GA IL LA MA ME MN ND NJ NY OH PA TX WA. Foreign distribution to Germany, Finland, Italy, Netherlands, and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated