Tag Archive for: recall

The U.S. health regulator said it had received reports of pediatric and adult patients suffering burn injuries when the tools, sold under the brand names MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes, were used on them.

The company’s “Albuterol Sulfate HFA Inhalation Aerosol” is a generic therapeutic equivalent version of an inhaler from Merck.

FDA identified the recall of Avanos Medical Inc.’s artificial airway tube for children and infants as the most serious type, as its use could lead to serious injuries or death.

Today the company clarified that 2.2 million devices it has repaired or replaced in a major recall of respiratory devices are actually in the hands of patients in the United States.

The FDA said the silicon foam used in some reworked ventilator models may separate from plastic backing due to adhesive failure and can reduce the air flow as well as cause debris contamination. The issue can lead to patient injury or death.

Datascope, a unit of Getinge, had recalled 4,454 therapeutic devices in December following a death and four serious injuries from their use.

Philips said the latest tests indicated that exposure to particulate matter emissions from degraded foam in DreamStation devices was “unlikely to result in an appreciable harm to health in patients”, provided the machines had not been treated with ozone-based cleansing products.