Recall Z-0594-2021— Cook Inc.

Name: FDA recall Z-0594-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-24

Class I · Terminated

Class I FDA medical device recall by Cook Inc., initiated 2020-11-24, terminated 2022-09-07. It names one FDA 510(k) clearance: K142829. Product: Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.. Reason: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage..

Recalling firm: Cook Inc.
Classification: Class I
Status: Terminated
Initiated: 2020-11-24
Terminated: 2022-09-07
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, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Reason for recall

There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.

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