Recall Z-1722-2025— Philips North America Llc
Class II · Ongoing
Class II FDA medical device recall by Philips North America Llc, initiated 2025-04-07. It names 5 FDA 510(k) clearances: K181467, K113441, K993383 and 2 more. Product: 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.. Reason: Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible..
- Recalling firm
- Philips North America Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-07
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
5 on FDA's record- K181467 — Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line
- K113441 — PHYSIOLOGICAL MONITOR, PATIENT MONITOR
- K993383 — HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B
- K980324 — MICROSTREAM FILLERLINE OR/EMS
- K980327 — MICROSTREAM FILTERLINE ICU
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
Data sourced from openFDA. This site is unofficial and independent of the FDA.