The FDA said it has requested additional safety testing on the material used to repair Royal Philips (NYSE:PHG) sleep therapy devices recalled for foam that could harm patients using them.
The Class I recall that started in June covers more than 15 million devices, after hundreds of complaints and more than 100 injuries from polyester-based polyurethane (PE-PUR) sound abatement foam that broke down, allowing foam and chemicals to potentially enter the device’s air pathway and cause health problems for users.
On Friday, the FDA said that upon inspection of a Philips Respironics manufacturing facility used to make replacement foam for the recalled devices, it learned that the silicone-based product failed a safety test for the release of volatile organic compounds (VOCs). That test was conducted on a similar device sold outside the U.S.