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Avanos Medical, Inc.

https://www.halyardhealth.com

Latest From Avanos Medical, Inc.

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.

Recalls Respiratory

GMP Violations Won’t Trigger Breach Of DOJ Compliance Agreement, Government Attorneys Say

Responding to concerns about ‘over criminalization’ of companies subject to deferred prosecution agreements, FDA and DOJ attorneys note that getting a form 483 won’t breach compliance provisions. Avanos Medical’s 2021 agreement is to be model going forward.

Compliance Enforcement

GMP Violations Won’t Trigger Breach Of DOJ Compliance Agreement, Government Attorneys Say

Responding to concerns about ‘over criminalization’ of companies subject to deferred prosecution agreements, FDA and DOJ attorneys note that getting a form 483 won’t breach compliance provisions. Avanos Medical’s 2021 agreement is to be model going forward.

Compliance Enforcement

US DOJ Settles With St. Jude, Alere, Avanos For Total Of $88M

The settlements resolve False Claims Act allegations against St. Jude and Alere, as well as misbranding allegations against Avanos Medical.

Regulation Enforcement
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Company Information

  • Industry
  • Pharmaceuticals
    • Drug Delivery
  • Medical Devices
    • Biomaterials
    • Infusion Therapy Equipment and Supplies
    • Radiofrequency Devices
    • Surgical Equipment & Devices
      • Surgical Sealants
    • Diagnostic Imaging Equipment & Supplies
      • Digital Imaging
  • Other Names / Subsidiaries
    • Halyard Health, Inc.
    • Summit Medical
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