Oridion Medical 1987 Ltd. is recalling approximately 14,700,798 Microstream CO2 sampling lines and airway adapters, including FilterLine, VitaLine, and CapnoLine products. The recall was issued because the airway adapters may be difficult or impossible to disconnect from a patient's breathing tube (endotracheal tube) during procedures like suctioning. No injuries have been reported, but this defect could lead to the breathing tube being accidentally pulled out, causing critical treatment delays or breathing failure.
If the adapter fails to disconnect properly, the force required to remove it could cause the patient's endotracheal tube to be pulled out of place. This poses a severe risk of respiratory failure, low oxygen levels (hypoxia), aspiration, and potentially life-threatening breathing complications, especially in neonatal and infant patients.
Microstream IFU 006147 Rev N
Microstream IFU MQ04616 Rev N
Microstream IFU 10129497 Rev B
Microstream IFU 01158 Rev E
Microstream IFU 012808 Rev E
Microstream IFU PT00134333 Rev A
Microstream IFU PT00134354 Rev A
Microstream IFU PT00156355 Rev A
Microstream IFU PT00156254 Rev A
Microstream IFU PT00156250 Rev A
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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