Recall Z-0185-2022— Cook Inc.

Name: FDA recall Z-0185-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-28

Class II · Terminated

Class II FDA medical device recall by Cook Inc., initiated 2021-09-28, terminated 2024-02-28. It names one FDA 510(k) clearance: K142829. Product: 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.. Reason: 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..

Recalling firm: Cook Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-09-28
Terminated: 2024-02-28
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K142829 — Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification +6 moreCook Incorporated·cleared 2015-07-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.