Microstream Neonatal-Infant CO2 Filter Line May Be Difficult to Disconnect
Microstream Neonatal-Infant Intubated CO2 Filter Lines may become difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially delaying treatment and causing unintended extubation.
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: This is an FDA Class II medical device with no reported illnesses or injuries. However, the recall addresses a risk-of-harm situation where difficulty disconnecting adapters could lead to treatment delays, unintended extubation, respiratory failure, hypoxia, and aspiration in critical care patients, meeting the criteria for High severity.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling Microstream Advance Neonatal-Infant Intubated CO2 Filter Lines (Part Number PT00134354, Revision A) due to a disconnection difficulty issue. The device adapters may become difficult or impossible to disconnect from the endotracheal tube during routine clinical procedures such as suctioning.
If the adapter cannot be disconnected as intended, it may delay necessary treatment and cause unintended extubation. These complications could lead to respiratory failure, hypoxia (low blood oxygen), aspiration, and dangerously low oxygen saturation, particularly in neonatal and pediatric patients dependent on mechanical ventilation.
The recall affects approximately 350 units distributed worldwide, including throughout all regions of the United States and internationally. Affected healthcare facilities should immediately inspect their inventory for the recalled devices and contact Oridion Medical 1987 Ltd. for guidance on device replacement or corrective actions.
The recalled product
- Product
- Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVIIH
- Manufacturer
- Oridion Medical 1987 Ltd.
- Hazard
- difficult-disconnect
- unintended-extubation
- respiratory-failure
- hypoxia
- aspiration
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 (1)
- C211085494)
Distribution
Distributed nationwide across the United States.
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