Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Microstream Instructions for Use and Part Number used with - Product Description Recalled by Oridion Medical 1987 Ltd. Due to Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Oridion Medical 1987 Ltd. directly.
Affected Products
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 FilterLine H Set Long Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 007738; MICROSTREAM VitaLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 010807.
Quantity: 318292
Why Was This Recalled?
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Oridion Medical 1987 Ltd.
Oridion Medical 1987 Ltd. has 47 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report