Philips North America LLC recalls Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intu…

Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.

Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Line LTerm Lng , Adt/Pedi Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line High Humidity , Neo/Inf Intub CO2 Line LTerm Lng , VitaLine H Set Adult/Pediatric , VitaLine H Set Infant/Neonatal , FilterLine Set Long Adult/Pediatric , FilterLine H Set Long Adult/Pediatric , FilterLine H Set Long Infant/Neonatal , Trade Compliant: FilterLine H, Adult/Ped , Trade Compliant: FilterLine H, Infant/Neo , FilterLine Set Adult/Pedi , FilterLine H Set Adult/Pedi and FilterLine H Set Infant/Neonatal. Carbon dioxide gas analyzer.

Consignees and Distributors were mailed an URGENT Medical Device Correction notice dated 4/7/25. Consignees were instructed to continue using the devices per the IFU and to ensure during setup that the airway adapter can easily be attached and detached from the breathing circuit/tubing before proceeding. The provided recall notification should be forwarded to those in the organization who use the device or where devices may have been transferred. Consignees are asked to utilize the provided QR code to complete a Response Form digitally; consignees can also email a hard copy Response Form to Recall.Response@fda.hhs.gov or by fax to 877-499-7723. Distributors are asked to forward the provided recall notification to customers no later than 5 days after notification of this recall event and to conduct a good faith effort to get a completed Response Form from each of their customers by conducting a minimum of three follow ups utilizing multiple contact methods. Consignees or Distributors with any questions are to contact 1-800-722-9377. Philips plans to issue an IFU addendum to address the recall.

• FDA enforcement recordOfficial FDA database entry for Z-1722-2025
• FDA 510(k) clearance · K113441The device's official FDA premarket clearance record
• FDA 510(k) clearance · K181467The device's official FDA premarket clearance record
• FDA 510(k) clearance · K980324The device's official FDA premarket clearance record
• FDA 510(k) clearance · K980327The device's official FDA premarket clearance record
• FDA 510(k) clearance · K993383The device's official FDA premarket clearance record
• FDA device classification · CCKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.1400The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Philips North America LlcSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.