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Philips Updates On CPAP, BiPAP And Mechanical Ventilator Recall Notification

Philips, in an update on earlier announced voluntary CPAP, BiPAP and Mechanical Ventilator recall notification, said Sunday that the US Food and Drug Administration recently conducted an inspection of a Philips Respironics manufacturing facility in connection with the recall. On November 12, 2021, the FDA published a list of the observations it provided to Philips Respironics.

The company noted that its subsidiary Philips Respironics will submit its response to the inspectional findings for review by the FDA. An FDA investigator's list of inspection observations does not constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. Additionally, the FDA has not changed its recommendation to patients and healthcare providers in relation to affected devices.

On June 14, 2021, Philips Respironics initiated a voluntary recall notification for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. Following the substantial ramp-up of its production, service, and repair capacity, the repair and replacement program in the US and several other markets is under way.

The company noted that Philips Respironics and certified testing laboratories have been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks, since June 2021.

Philips Respironics plans to make more data available to the relevant competent authorities as soon as possible after completing the assessment of the above mentioned research and tests, which is anticipated to take place in the fourth quarter.

Separately, Philips Respironics has conducted testing to support the new silicone replacement foam. Silicone foam testing provided by Philips Respironics to the FDA on devices authorized for marketing in the US had demonstrated acceptable results.

Philips Respironics continues to coordinate with the FDA and other competent authorities on its testing.

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