Philips Respironics is recalling 215 of its Trilogy Evo ventilators and 51 repair kits due to the risk of death or serious injury posed by possibly carcinogenic polyester-based polyurethane (PE-PUR) sound abatement foam included in the products.
According to a recall notice, which the U.S. Food and Drug Administration has categorized as Class 1 (the most serious), a Philips supplier incorrectly used the polyurethane foam in the muffler assembly of the affected Trilogy Evo ventilators and repair kits.
The company is recalling the Trilogy Evo ventilators with model numbers DS2110X11B and KR2110X15B (not distributed in the U.S.) and repair kits for Trilogy Evo muffler assembly with part number 1135257 and lot number between 210414 and 210524.
It says the devices were made and distributed in the U.S. and Korea between April and May 2021.
According to the recall notice, the issue was identified during lab testing. Luckily, there have been no reported injuries or death to date.
The PE-PUR foam, which is used to reduce sound and vibration in the devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device, the recall notice says.
Philips Respironics says the Trilogy Evo O2, Trilogy EV300 and Trilogy Evo Universal models are not affected by the issue and are not subject to the recall.
The company says that those using the recalled ventilators should not stop or change therapy unless they have consulted their health care provider or unless a replacement Trilogy Evo ventilator has been provided.
Instead, it is urging users to closely monitor the bacteria filter for foam debris and to use an inline bacterial filter to help filter out particles of foam. However, it says that bacterial filters will not help to reduce exposure to certain chemicals that may be released from the PE-PUR foam.
Customers in the U.S. with questions about this recall should contact Philips Respironics at 1-800-722-9377 or email Respironics.repair@philips.com.
Philips has recalled a range of its ventilators, including Trilogy 100 and 200 ventilators and CPAP and BiPAP machines over the past year due to the risks posed by PE-PUR foam, and it is facing multiple lawsuits due to exposing consumers to the possibly deadly substance.
If you used one of the recalled Philips ventilator or CPAP machines and have been diagnosed with cancer or a lung injury, you may be eligible to join a free lawsuit investigation to seek compensation for your medical expenses, lost wages and other damages.
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Philips Respironics is recalling 215 of its Trilogy Evo ventilators and 51 repair kits due to the risk of death or serious injury posed by possibly carcinogenic polyester-based polyurethane (PE-PUR) sound abatement foam included in the products.... Read More
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