Philips neonatal and adult CO2 filter line adapter may not disconnect
Philips neonatal and adult CO2 filter lines may have adapters that are difficult or impossible to disconnect from endotracheal tubes. This Class II recall affects approximately 486,631 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a potential adapter disconnection hazard in critical-care settings for intubated patients, but no reported injuries or illnesses. Per the rubric, a risk-of-harm product where injury has not yet been reported scores at 3 (High).
Plain-English summary
Philips North America is recalling multiple CO2 filter line products used in intubation, including the Microstream Advance Neonatal-Infant Intubated CO2 Filter Lines and related devices (marketed under names including Adt/Pedi Intub CO2 Line, Neo/Inf Intub CO2 Line, VitaLine H Set, and FilterLine variants). These are carbon dioxide gas analyzers used to monitor CO2 during intubated patient care.
The adapter that connects the filter line to the endotracheal tube can potentially be difficult or impossible to disconnect. This condition may impede normal patient management procedures.
Approximately 486,631 units have been distributed worldwide, including throughout the United States and numerous other countries. The FDA classified this as a Class II recall.
The recalled product
- 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 ,
- Manufacturer
- Philips North America Llc
- Hazard
- adapter-disconnection
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. 989803204511
- 989803204321
- 989803204301
- 989803204331
- 989803204521
- 989803204531
- 989803204311
- 989803204341
- 989803159571
- 989803159581
- 989803160241
- 989803160251
- 989803160261
- 989803182921
- 989803182931
- 989803105531
- 989803105541
- 989803105561
- UDI: N/A
- System Codes 989803105531
Distribution
Distributed nationwide across the United States.
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