FDA Device recall Z-1385-2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - M…
- FDA Device
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - M… by Oridion Medical 1987, citing 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 dis….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1385-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-17 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Oridion Medical 1987 |
| Distribution | US |
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVIIH; Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft High Humidity, MVIIHH; Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 4m/13ft Extended Duration, MVIIHL; Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, ZMVIIH
Reason
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.
Identifiers
| code_info | Part Number and Revision - REF/UDI-DI(Lot): PT00156250 Rev A - MVIIH/20884521761985(C220646817, C220650235, C220858…Part Number and Revision - REF/UDI-DI(Lot): PT00156250 Rev A - MVIIH/20884521761985(C220646817, C220650235, C220858356, C220865467, C230417501, C231048771, C240417204, C240522125, C240624670, D181134920, D181134922, D201159585), 10884521761988(C210415594, C210525057, C211101243, C211105839, C211213507, C220103340, C220213101, C220213102, C220317965, C220319423, C220646813, C220646817, C220650235, C220858356, C220865467, C220974773, C220978900, C221088533, C230314185, C230417501, C230519978, C230733063, C230939108, C231045651, C231048771, C231158575, C231158576, C240100232, C240417204, C240522125, C240624670, C240729892, C240933087, D181134920, D181134921, D181134922, D181134923, D181134924, D181134925, D181134926, D181134927, D181134928, D201159585, D210104103, D210204364, D210204367, D211046862, D211157160, D211157889, D220102589, D220207940, D220632263, D220632264, D220632267); MVIIHH/10884521762015(C210415656, C211070952, C220108515, C220213149, C220319472, C220540880, C2208631 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1385-2025%22
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