Notes
Notes - notes.io |
FDA's Most Dangerous Recalls 2022 Unplaced Feeding Tubes The most feared (Avanos Medical)
According to FDA recalls, Avanos Medical Cortrak2 is the most dangerous medical device.
While 2022 isn't completed, FDA already has 50 medical devices listed on the recall list. The result of the recalls to date is unfortunate, with 36 deaths and the number of injuries is 224. Avanos Medical ranks number one on the 2022 medical device malfunctions list with 23 reported deaths from unintentionally placed feeding tubes.
These are the 4 deadliest medical device malfunctions as per the FDA medical device recall Notice:
Avanos Medical Recalls Cortrak*2 Enteral Access System for feeding tubes
The improper placement of nasogastric feeding tubes led to 60 injuries and 23 deaths.
In 2022 , this device malfunction was the most significant cause of death for all recalled medical equipment.
Avanos Medical has recalled the Cortrak*2 Enteral Access System due to reports of injuries and deaths resulting from nasoenteric and nasogastric feeding tubes have been installed incorrectly.
If a nasogastric or nasal, or nasoenteric, tube has been incorrectly installed, patients could be harmed by their vocal cords, lungs, or trachea. This could result in serious injury and even death. Avanos Medical notified that patients "...and hospitals must confirm the location of N/NI tubes according to institution protocol. Avanos Medical feeding tube Fox News covered the story.
Cortrak 2 eternal access system Avanos Medical's recall communications reported the injuries and deaths related to the misplacement of the enteral feeding tubes during the use of the CORTRAK* 2 Enteral Access System, which was introduced in 2015.
Avanos Medical feeding tube Baxter recalls SIGMA Spectrum Infusion Systems, which includes Master Drug Library (Version 8) & Spectrum IQ Infusion Systems (Version 9)
Baxter received 51 serious injuries and three death of patients in the past five years.
The medical device manufacturer Baxter recalls this device after numerous reports of a malfunctioning safety alarm. The alarms on the pumps was not able to trigger in the event of occlusions in the upstream. The announcement warned users that using these affected products may cause negative health effects, such as death.
Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube
There have been three accidents and 2 deaths attributed with the use of this device.
Three injuries and two deaths were caused by the NIMCONTACT Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube both of which are used to monitor laryngeal and head nerves. Although the company hasn't asked customers to return the defective devices or to replace them, they sent warnings about safety to make sure that the cuff made of silicone didn't hinder a patient's breathing.
Patients can experience an oxygen deficiency, brain injury or even death if tube isn't ventilated correctly.
https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding Baxter Healthcare Corporation Recalls Volara System
There have been one death and 1 injury by the use of this device.
Baxter Healthcare Corporation is recalling its Volara system subsidiary, Hillrom. The adaptor connected to ventilators may prevent patients who use the ventilator at home from getting enough oxygen. Patients at risk include those who breath in mucus, respiratory failure (pneumonia) or brain injuries (hypoxia), and the possibility of choking.
Avanos Medical Here is the list of the human life-saving costs in 2022 for medical device malfunctions or abuse:
Avanos Medical Recalls Cortrak*2 Enteral Access System
Injuries: 60
Deaths: 23
Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) occlusion events
Injuries: 51
Deaths: 3
Medtronic recalls NIMCONTACT Reinforced Endotracheal Tube with EMG Reinforcement , as well as the NIM Standard Reinforced Endotracheal Tube
Injuries: 3
Deaths: 2
Baxter Healthcare Corporation Recalls Volara System
Injuries: 1
Deaths: 2
Smiths Medical Recalls Certain Medfusion 4000 and 3500 Syringe Pumps for Infusion
Injuries: 7
Deaths: 1
Medtronic recalls HVAD HeartWare system batteries
Injuries: 6
Deaths: 1
Philips Respironics recalls all V60 and V60 Plus ventilatilators
Injuries: 4
Deaths: 1
Medtronic Recalls HVAD Pump Kit
Injuries: 2
Deaths: 1
Medtronic recalls heartWare's batteries HVAD system
Injuries: 0
Deaths: 1
Covidien, LP Recalls Puritan Bennett 980 Series Ventilator
Injuries: 0
Deaths: 1
Medtronic Inc. Recalls HawkOne Directional Atherectomy System
Injuries: 55
Deaths: 0
Arrow International, LLC, Subsidiary of Teleflex Inc., recalls the Arrow-Trerotola PercutaneousThrombolytic Device
Injuries: 14
Deaths: 0
Atrium Medical Corporation recalls iCast with a sten cover.
Injuries: 9
Deaths: 0
Vyaire Medical Recalls Bellavista 1000 and 1000e Series Ventilators
Injuries: 7
Deaths: 0
LivaNova (TandemLife) Recalls LifeSPARC System
Injuries: 2
Deaths: 0
Draeger, Inc recalls SafeStar 55 Breathing Systems Filters
Injuries: 1
Deaths: 0
Abbott Medical Recalls Dragonfly OpStar Imaging Catheter
Injuries: 1
Deaths: 0
SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests
Injuries: 1
Deaths: 0
Read More: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its
According to FDA recalls, Avanos Medical Cortrak2 is the most dangerous medical device.
While 2022 isn't completed, FDA already has 50 medical devices listed on the recall list. The result of the recalls to date is unfortunate, with 36 deaths and the number of injuries is 224. Avanos Medical ranks number one on the 2022 medical device malfunctions list with 23 reported deaths from unintentionally placed feeding tubes.
These are the 4 deadliest medical device malfunctions as per the FDA medical device recall Notice:
Avanos Medical Recalls Cortrak*2 Enteral Access System for feeding tubes
The improper placement of nasogastric feeding tubes led to 60 injuries and 23 deaths.
In 2022 , this device malfunction was the most significant cause of death for all recalled medical equipment.
Avanos Medical has recalled the Cortrak*2 Enteral Access System due to reports of injuries and deaths resulting from nasoenteric and nasogastric feeding tubes have been installed incorrectly.
If a nasogastric or nasal, or nasoenteric, tube has been incorrectly installed, patients could be harmed by their vocal cords, lungs, or trachea. This could result in serious injury and even death. Avanos Medical notified that patients "...and hospitals must confirm the location of N/NI tubes according to institution protocol. Avanos Medical feeding tube Fox News covered the story.
Cortrak 2 eternal access system Avanos Medical's recall communications reported the injuries and deaths related to the misplacement of the enteral feeding tubes during the use of the CORTRAK* 2 Enteral Access System, which was introduced in 2015.
Avanos Medical feeding tube Baxter recalls SIGMA Spectrum Infusion Systems, which includes Master Drug Library (Version 8) & Spectrum IQ Infusion Systems (Version 9)
Baxter received 51 serious injuries and three death of patients in the past five years.
The medical device manufacturer Baxter recalls this device after numerous reports of a malfunctioning safety alarm. The alarms on the pumps was not able to trigger in the event of occlusions in the upstream. The announcement warned users that using these affected products may cause negative health effects, such as death.
Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube
There have been three accidents and 2 deaths attributed with the use of this device.
Three injuries and two deaths were caused by the NIMCONTACT Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube both of which are used to monitor laryngeal and head nerves. Although the company hasn't asked customers to return the defective devices or to replace them, they sent warnings about safety to make sure that the cuff made of silicone didn't hinder a patient's breathing.
Patients can experience an oxygen deficiency, brain injury or even death if tube isn't ventilated correctly.
https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding Baxter Healthcare Corporation Recalls Volara System
There have been one death and 1 injury by the use of this device.
Baxter Healthcare Corporation is recalling its Volara system subsidiary, Hillrom. The adaptor connected to ventilators may prevent patients who use the ventilator at home from getting enough oxygen. Patients at risk include those who breath in mucus, respiratory failure (pneumonia) or brain injuries (hypoxia), and the possibility of choking.
Avanos Medical Here is the list of the human life-saving costs in 2022 for medical device malfunctions or abuse:
Avanos Medical Recalls Cortrak*2 Enteral Access System
Injuries: 60
Deaths: 23
Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) occlusion events
Injuries: 51
Deaths: 3
Medtronic recalls NIMCONTACT Reinforced Endotracheal Tube with EMG Reinforcement , as well as the NIM Standard Reinforced Endotracheal Tube
Injuries: 3
Deaths: 2
Baxter Healthcare Corporation Recalls Volara System
Injuries: 1
Deaths: 2
Smiths Medical Recalls Certain Medfusion 4000 and 3500 Syringe Pumps for Infusion
Injuries: 7
Deaths: 1
Medtronic recalls HVAD HeartWare system batteries
Injuries: 6
Deaths: 1
Philips Respironics recalls all V60 and V60 Plus ventilatilators
Injuries: 4
Deaths: 1
Medtronic Recalls HVAD Pump Kit
Injuries: 2
Deaths: 1
Medtronic recalls heartWare's batteries HVAD system
Injuries: 0
Deaths: 1
Covidien, LP Recalls Puritan Bennett 980 Series Ventilator
Injuries: 0
Deaths: 1
Medtronic Inc. Recalls HawkOne Directional Atherectomy System
Injuries: 55
Deaths: 0
Arrow International, LLC, Subsidiary of Teleflex Inc., recalls the Arrow-Trerotola PercutaneousThrombolytic Device
Injuries: 14
Deaths: 0
Atrium Medical Corporation recalls iCast with a sten cover.
Injuries: 9
Deaths: 0
Vyaire Medical Recalls Bellavista 1000 and 1000e Series Ventilators
Injuries: 7
Deaths: 0
LivaNova (TandemLife) Recalls LifeSPARC System
Injuries: 2
Deaths: 0
Draeger, Inc recalls SafeStar 55 Breathing Systems Filters
Injuries: 1
Deaths: 0
Abbott Medical Recalls Dragonfly OpStar Imaging Catheter
Injuries: 1
Deaths: 0
SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests
Injuries: 1
Deaths: 0
Read More: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its
|
|
Notes is a web-based application for online taking notes. You can take your notes and share with others people. If you like taking long notes, notes.io is designed for you. To date, over 8,000,000,000+ notes created and continuing...
With notes.io;
- * You can take a note from anywhere and any device with internet connection.
- * You can share the notes in social platforms (YouTube, Facebook, Twitter, instagram etc.).
- * You can quickly share your contents without website, blog and e-mail.
- * You don't need to create any Account to share a note. As you wish you can use quick, easy and best shortened notes with sms, websites, e-mail, or messaging services (WhatsApp, iMessage, Telegram, Signal).
- * Notes.io has fabulous infrastructure design for a short link and allows you to share the note as an easy and understandable link.
Fast: Notes.io is built for speed and performance. You can take a notes quickly and browse your archive.
Easy: Notes.io doesn’t require installation. Just write and share note!
Short: Notes.io’s url just 8 character. You’ll get shorten link of your note when you want to share. (Ex: notes.io/q )
Free: Notes.io works for 14 years and has been free since the day it was started.
You immediately create your first note and start sharing with the ones you wish. If you want to contact us, you can use the following communication channels;
Email: [email protected]
Twitter: http://twitter.com/notesio
Instagram: http://instagram.com/notes.io
Facebook: http://facebook.com/notesio
Regards;
Notes.io Team
