Microstream CO2 sampling lines recalled for difficult adapter disconnection
Microstream CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended tube removal.
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 a Class II FDA recall of a critical medical device. Although no illnesses or injuries have been reported, the potential for unintended extubation and respiratory failure during patient care qualifies it as a risk-of-harm product, meeting the criteria for High severity.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling Microstream CO2 sampling lines and filter line adapters used with endotracheal tubes for neonatal, infant, adult, and pediatric patients. Approximately 31,175 units have been distributed worldwide.
The recalled devices may be difficult or impossible to disconnect from endotracheal tubes during procedures such as suctioning. This disconnection difficulty may cause treatment delays and could result in unintended extubation (removal of the breathing tube).
Unintended extubation could lead to serious complications including respiratory failure, hypoxia (low oxygen levels), aspiration, and/or low oxygen saturation.
The recalled product
- Product
- Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), 006324COV; CapnoLine
- Manufacturer
- Oridion Medical 1987 Ltd.
- Hazard
- disconnection-difficulty
- 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 (4)
- D201260758)
- XS04620COV/10884521531529(D200322148
- D200742380)
- XS04624COV/10884521531536(D200320376)
Distribution
Distributed nationwide across the United States.
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