The FDA has classified Koninklijke Philips NV's (NYSE:PHG) expanded recall of certain ventilators late last year as Class 1, or the most serious type of recall.
- According to the FDA announcement, a Philips supplier had incorrectly used the polyurethane foam, which is intended to reduce sound and vibration, in one of the parts of the Trilogy Evo ventilators.
- This issue was identified during lab testing, according to the regulator.
- Also See: Philips Registers 10% Comparable Sales Decline In Q4.
- The FDA said that the foam could break down and potentially enter the device's air pathway, leading to the user inhaling chemicals or other harmful materials.
- The Company initiated the recall of 215 Trilogy Evo ventilators and 51 repair kits in the U.S. in December due to potential health risks from a type of foam used in the devices.
- So far, there have been no reported injuries or deaths from the products, which were distributed in the U.S. and Korea.
- This is the latest recall by Philips to be labeled Class 1 after it pulled back up to 4 million breathing-aid machines last year amid concerns that a polyurethane foam used in the devices could degrade and become toxic.
- Earlier this month, the Company raised that estimate by 1 million.
- Price Action: PHG shares are down 2.17% at $31.50 during the premarket session on the last check Thursday.
