FDA designates Class 1 recalls for closed suction systems, infant heated wire circuits, pediatric emergency tape

Editor's Note

Recent recalls of the Ballard Closed Suction Systems from Avanos Medical Inc., Infant Heated Wire Circuits from AirLife/Vyaire, and Broselow Pediatric Emergency Rainbow Tape from AirLife have been designated as Class 1, the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or death.

The Ballard Closed Suction Systems, used to remove airway secretions in patients on ventilators, were recalled due to a failure in the sterilization process. Risks include infection, airway injury, prolonged inflammation, sepsis, or death. No serious injuries or deaths had been reported. As detailed in the FDA’s July 10 announcement, users should immediately stop using the affected product, quarantine any remaining inventory, and return the devices to Avanos.

AirLife/Vyaire is recalling Infant Heated Wire Circuits due to the potential of accessory adapters provided with the product unintentionally disconnecting during setup or use when the circuit reaches operating temperature. Patient risks include hypoxia, hypercapnia, organ failure, and death. No serious injuries or deaths have been reported. Further information is available in FDA's July 9 announcement.

AirLife is also recalling certain Broselow Pediatric Emergency Rainbow Tapes-- color-coded length-based tape measures used to dose medicine, determine equipment sizes, and more—due to incorrect information. Specifically, the red zone contains incorrect joules in the cardioversion and defribrillation section, leading to risk of shock and associated burns, heart damage, and cardiac arrest. The orange and grey zones contain incorrect sodium bicarbonate concentration information, which can result in metabolic alkalosis, electrolyte imbalances, tissue damage, and worsened respiratory status for the orange zone and myocardial contractility, decreased vasopressor response, and dysrhythmia for the grey zone. Full information is available in FDA’s July 9 announcement.