Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5ft Short-term use: Procedural/Emergency, MLAI
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part Number and Revision - REF/UDI-DI(Lot): PT00156355 Rev A- MLAI/10884521762145(C210103390, C210103391, C210103392, C220100198, C220101566, C220210015, C220212812, C220430762, C220650161, C220975826, C221087553, C230208559, C230627706, C230733095, C240624686, D201159627, D201262180, D210206012)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Oridion Medical 1987 Ltd.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5ft Short-term use: Procedural/Emergency, MLAI
Product Codes/Lot Numbers:
Part Number and Revision - REF/UDI-DI(Lot): PT00156355 Rev A- MLAI/10884521762145(C210103390, C210103391, C210103392, C220100198, C220101566, C220210015, C220212812, C220430762, C220650161, C220975826, C221087553, C230208559, C230627706, C230733095, C240624686, D201159627, D201262180, D210206012)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1383-2025
Related Recalls
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.
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.
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.