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

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Cook recalls tracheostomy equipment

Cook recalls tracheostomy equipment

July 21, 2010 By MassDevice staff

Cook logo

Cook Medical initiated a voluntary recall of its percutaneous tracheostomy devices that contain a Covidien (NYSE:COV) 6PERC or 8PERC Shiley tube.

According to the Food & Drug Administration, the Bloomington, Ind.-based medical product manufacturer’s recall comprises 17 lots of the ‘Ciaglia Blue Rhino’ and ‘Ciaglia Blue Dolphin’ introducer sets and trays.

In April, Covidien voluntarily recalled some of its Shiley tracheostomy tubes over problems with the devices’ pilot balloons. The Mansfield, Mass.-based medical products giant’s tubes are designed to keep patients’ airways open using small balloons through which breathing tubes pass. Some of the devices can malfunction due to “the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly,” according to the FDA.

The problem could result in sudden decreases in blood oxygen or sudden increases in carbon dioxide in the blood, according to the agency, which in turn could lead to serious injury or death. Covidien sent a letter to customers April 13 detailing the potential problems and instructing them to return any affected products for replacement.

The FDA said Cook mailed a letter to affected Ciaglia customers that detailed the recall. Here’s a list of the affected devices:

Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Sets/Trays Reorder Number

Global Part  Number

C-PTIS-100-A-HC-PERC8

G12403

C-PTISY-100-A-HC-PERC8

G12566

C-PTIS-100-HC-PERC6

G13165

C-PTIS-100-HC-PERC6-CA

G36037

C-PTISY-100-HC-PERC6

G13166

C-PTIS-100-HC-PERC8

G12523

C-PTIS-100-HC-PERC8-CA

G36038

C-PTISY-100-HC-PERC8

G12565

C-PTISY-100-HC-G-PERC6

G53178

C-PTISY-100-WCE-HC-G-PERC6

G53169

C-PTISY-100-WCE-HC-G-PERC8

G53170

Table 2. Ciaglia Blue Dolphin Products

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets/Trays Reorder Number

 

Global Part  Number

C-PTBS-2600-PERC6

G36116

C-PTBSY-2600-PERC6

G36118

C-PTBSYJC-2600-PERC6

G51971

C-PTBS-2800-PERC8

G36117

C-PTBSY-2800-PERC8

G49507

C-PTBSYJC-2800-PERC8

G51972

Filed Under: Business/Financial News, News Well, Recalls, Respiratory Tagged With: Cook Medical

More recent news

  • Accelus wins FDA clearance for MRI compatibility of FlareHawk spinal implants
  • Presidio wins FDA IDE for ultra-low frequency neuromod, hires new CFO
  • Epiminder study backs implantable EEG tech
  • Neurent Medical wins FDA nod for next-gen chronic rhinitis treatment
  • Medtronic unveils “MiniMed” as name for soon-to-be separated Diabetes unit

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · 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.

Privacy Policy