Microstream CO2 Intubated Filter Lines Difficult to Disconnect
Microstream CO2 filter lines used with intubated patients may be difficult or impossible to disconnect from the endotracheal tube, potentially delaying treatment or 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 recall with serious potential risks (respiratory failure, hypoxia from unintended extubation) but no reported illnesses, injuries, or hospitalizations in the source text. Per the severity rubric, theoretical risks without reported harm score at most 3.
Plain-English summary
Microstream Advanced Adult-Pediatric Intubated CO2 Filter Lines (Part Numbers PT00134333 variants QMVAI and QMVAIH) are subject to this recall. These devices are used to sample carbon dioxide from the airways of patients on mechanical ventilation.
The adapter connecting the CO2 filter line to the endotracheal tube may be difficult or impossible to disconnect. This disconnection difficulty can impede routine clinical procedures such as suctioning and may result in treatment delays or unintended extubation of the endotracheal tube.
Unintended extubation and delayed treatment can lead to serious respiratory complications including respiratory failure, hypoxia, aspiration, and low oxygen saturation.
Approximately 3,800 units have been distributed worldwide, including throughout all 50 U.S. states and numerous countries internationally.
The recalled product
- Product
- Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, QMVAI; Microstre
- Manufacturer
- Oridion Medical 1987 Ltd.
- Hazard
- adapter-disconnection-difficulty
- respiratory-failure
- hypoxia
- extubation-unintended
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)
- QMVAIH/10884521762336(C210314314)
Distribution
Distributed nationwide across the United States.
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