The US Food and Drug Administration (FDA) announced that Philips has recalled its few bi-level positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines.
According to the FDA, the machines may contain plastic contaminated with a non-compatible material that could leak hazardous chemicals known as volatile organic compounds (VOCs) if the material is placed in the device’s motor.
The contaminated plastic could cause the device to fail and abruptly stops functioning while in use which can eventually lead to a serious injury or death.
In June last year, Philips recalled some of the BiPAP machines due to the PE-PUR foam issue.
On 26 August 2022, a letter regarding an urgent medical device recall was sent by the firm to concerned clients, including providers of durable medical equipment (DME).
A bi-level positive airway pressure machine pumps air into the lungs’ airways at various pressures and the machines employ a higher pressure than when the user exhale.
The devices are prescribed for persons who have obstructive sleep apnea syndrome, respiratory insufficiency, or respiratory failure to keep their airways open while they sleep.
Depending on the directions for usage for the specific device model, the devices may be used to treat adult and paediatric patients at home as well as in clinical settings.
The FDA said that it is aware that patients’ dependence on these devices and is closely watching the company’s activities to make sure the problems are fixed as soon as possible.
For this recall, the FDA is examining the plan the company has put forth to address the issue and evaluating the health risk the product poses.
Intera Oncology has also recalled Intera 3000 Hepatic Artery Infusion Pump due to abnormal flow rates that may impact infusion delivery.
The FDA has classified the recall as Class I recall, which may cause serious injuries or death.
The Intera 3000 Hepatic Artery Infusion Pump is intended to continually give medication via an artery that supplies blood and oxygen to the liver and several other organs.
People who use the Infusion Pump can resume their regular activities and visit the hospital every two weeks to get their pumps refilled.
The Pump is being recalled by Intera as a result of concerns from doctors that the pumps were dispensing medication (flow rate) more quickly than was anticipated.
