CO2 Sampling Lines May Fail to Disconnect During Neonatal Care
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended extubation. The defect affects neonatal and pediatric patients 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 device with serious potential consequences (respiratory failure, hypoxia) if the disconnection failure occurs, but no reported illnesses or injuries have been documented. Per the rubric, this qualifies as High severity—a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Microstream CO2 sampling lines and airway adapters are medical devices used to measure carbon dioxide levels during neonatal, infant, and adult-pediatric patient care. The recalled products include the FilterLine H Set (Part 006147), FilterLine H Set Long (Part 007738), and VitaLine H Set (Part 010807), distributed worldwide in approximately 318,292 units.
These devices may fail to disconnect properly from endotracheal tubes used during patient intubation. Users may experience difficulty or inability to remove the adapter during standard medical procedures such as suctioning.
If the adapter cannot be disconnected, treatment may be delayed. In some cases, attempting to disconnect a stuck adapter may cause unintended extubation (removal of the breathing tube). These complications could potentially lead to respiratory failure, hypoxia (low oxygen levels), aspiration, or dangerously low oxygen saturation. No injuries have been reported to date.
Affected patients and healthcare providers should contact Oridion Medical 1987 Ltd. immediately if they have received or used these devices. Healthcare facilities should review patient care records for any incidents related to adapter disconnection difficulties and monitor patients accordingly.
The recalled product
- Product
- Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM
- Manufacturer
- Oridion Medical 1987 Ltd.
- Hazard
- disconnect-failure
- unintended-extubation
- respiratory-failure
- hypoxia
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)
- C210957017
- C211102266
- C211206691
- C220108497
- D191171644
- D191171646
- D191176150
- D191278690
- D200316307
- D200538149
- D200639546
- D200742524
- D200745256
- D200950569
- D200951852
- D201055941
- D201261296
- D210101027
- D210103472
- D210310524
Distribution
Distributed nationwide across the United States.
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