• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Medical Tubing and Extrusion

Medical tubing and extrusion technologies

  • Catheters
  • Components
    • Connectors
    • Needles and Injections
    • Seals
    • Tubing Components
  • Manufacturing
    • Coatings
    • Extrusions
    • Machining
    • Injection Molding
    • Insert molding
    • Tools
  • Materials
    • Advanced Materials
    • Silicone
  • Research & Development
  • Suppliers

Cook Medical has a serious catheter recall

December 28, 2020 By Chris Newmarker

Cook MedicalFDA has designated Cook Medical‘s recall of its Flexor Check-Flo introducers and Flexor tuohy-borst side-arm introducers as Class I, its most serious level.

Cook Medical initiated the recall on Nov. 24. It involves 37,326 of the devices, which are used to deliver medical devices to blood vessels (though not vessels of the heart and brain). The Flexor devices involved in the recall have an increased chance of separating at a specific point, the proximal bond site, FDA said last week in its announcement of the Class I designation.

FDA said there have been 57 complaints about the problem, with 14 reports of serious injuries. There are no reported deaths.

Cook Medical in its Urgent Medical Device Recall notification letter told health providers to return the devices and immediately report adverse events to the Bloomington, Ind.–based company’s medical customer relations.

The Flexor introducers involved in the recall were made between Feb. 17 and Sept. 29, and distributed between May 23 and Nov. 17.

Cook Medical Flexor introducers recall
Pictures of the Flexor Check-Flo introducer and the Flexor tuohy-borst side-arm Introducer (shuttle select) with a red arrow showing where separation usually happens (proximal bond site). [Image courtesy of FDA]

Filed Under: Catheters Tagged With: Cook Medical, fda

Primary Sidebar

DeviceTalks Tuesdays

DeviceTalks Tuesdays
MDO ad

Stay Current

Need Medical Tubing news in a minute?
We Deliver!

Medical Tubing + Extrusion newsletter get you caught up on all the mission critical news you need in medical tubing. Sign up today.

Enews Sign up

Sponsored Content

A new way to access scientific papers?

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website

Footer

Inv Logo

MASSDEVICE MEDICAL NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech 100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Souring
R&D World

Medical Tubing & Extrusion

Subscribe to our e-newsletter
Advertise with us
About
Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS