Recall Of Avanos’ Pediatric Airway System Get Class I Designation

Avanos Medical has recalled 1,000 devices that provide access to the artificial airway in pediatric patients due to cracked openings in the system during use. The US FDA has labelled the recall class I, the agency’s most serious type.

FDA RECALL
• Source: Shutterstock

After receiving complaints from customers about cracked manifolds in the tubes of its Ballard Access Closed Suction System, Avanos Medical issued a recall of 1,000 devices.

The Alpharetta, Georgia-based company initiated the recall in February for the devices that were distributed in the US between 20...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Recalls

Serious Injuries Tied To Medtronic Bravo GERD Diagnosing System

 

The US FDA has issued an early alert to notify consumers about serious risks associated with a recall from Medtronic and its subsidiary Given Imaging. The alert concerns delivery capsules for diagnosing GERD.

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

California Medtech Firms Resolve Patent Dispute Over Delivery Catheters

 

Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.

More from Policy & Regulation

UK Trails NHS 10-Year Plan With Launch Imminent

 
• By 

Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.

New EU Rules Limit Chinese Participation In Medtech Procurement

 

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

Mexico’s New Procurement Rules Aim To Increase Healthcare Investment, But May Face Legal Trouble

 

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.