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Philips Has a Problem with Plastics

Image: Alexey Novikov/Adobe Stock recall
After the 2021 recall of breathing devices because of degraded PE-PUR foam, the company now is recalling BiPAP machines that may harbor a contaminated plastic part.

FDA issued an alert earlier this week to notify patients and healthcare providers that Philips Respironics has recalled some of its bi-level positive airway pressure (BiPAP) machines because they may contain a plastic contaminated with a non-compatible material. If the plastic is in the device motor, it may release volatile organic compounds (VOCs), chemicals of concern that can irritate the eyes, nose, and throat and cause difficulty breathing. That can be especially problematic in BiPAP machines, because they are designed to help patients who already have difficulty breathing.

The recall affects 386 BiPAP machines that were distributed in the United States between Aug. 6, 2020, and Sept. 1, 2021. Philips sent users of those devices a recall letter on Aug. 26, 2022. Since then, Philips reportedly expanded the recall globally to a total of 1,700 devices.

FDA stressed in the alert that this recall is not associated with Philip’s major recall of breathing devices and ventilators in June 2021. However, in both cases, the trigger appears to be plastic parts.

In the 2021 recall, the culprit was polyester-based polyurethane (PE-PUR) foam, used to dampen the sound of the respiratory device, that could degrade and emit small particles. They could enter the air pathway of the device and be inhaled or ingested by the user. The foam may also off-gas chemicals that could be harmful and potentially cancerous.

The most recent recall involves a relatively small number of machines identified by serial numbers published in the FDA alert and in the Urgent Medical Device Recall letter sent by Philips Respironics.

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