Philips Microstream Advance Neonatal-Infant CO2 Filter Line Adapter Disconnection Risk
Philips is recalling Microstream Advance Neonatal-Infant Intubated CO2 Filter Lines and related products because the adapter may be difficult or impossible to disconnect from the endotracheal tube.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall of a medical device where patient harm could occur if the adapter cannot be disconnected during clinical care of intubated patients (neonatal and pediatric populations). The source text identifies a risk-of-harm condition (difficulty or inability to disconnect) without reporting actual illnesses or injuries, which per the rubric corresponds to a High (score 3) severity.
Plain-English summary
Philips North America LLC is recalling multiple models of Microstream Advance Neonatal-Infant Intubated CO2 Filter Lines and related products marketed under several names including Adt/Pedi Intub CO2 Line, Neo/Inf Intub CO2 Line, VitaLine H Set, and FilterLine Set variants. These are carbon dioxide gas analyzer filter lines used in intubated patients.
The recall is due to a potential disconnection issue: the adapter connecting the filter line to the endotracheal tube may be difficult or impossible to disconnect. This could complicate clinical procedures and patient care management.
Approximately 486,631 units have been distributed worldwide, including throughout the United States and numerous international locations. Healthcare facilities and providers using these products should contact Philips for guidance on affected units and management of this issue.
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
- Affected units
- 486,631
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
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