FDA Device recall Z-1376-2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 0…
- 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: FilterLine H Set & VitaLine H Set Infant/Neonatal, 0… 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-1376-2025 |
| 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: 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.
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): 006147 Rev N - 006324/20884521551692(C210417257, C210957017, C211102266, C2…Part Number and Revision - REF/UDI-DI(Lot): 006147 Rev N - 006324/20884521551692(C210417257, C210957017, C211102266, C211206691, C220108497, D191171644, D191171646, D191176150, D191278690, D200316307, D200538149, D200639546, D200742524, D200745256, D200950569, D200951852, D201055941, D201261296, D210101027, D210103472, D210310524, D210413725, D210726722, D220211210), 10884521551695(D191171644, D191171646, D191176150, D191278690, D200316307, D200745256, D201261296, D210103472); 007738/20884521216010(D191069375, D191171650, D191176156, D200314292, D200431907, D200537959, D200742194, D200745606, D200950373, D201260700, D210308577, D210728936, D211047680, D211155459); 010807/20884521551920(D200101284, D200426597, D200742219, D200745037, D201260710, D210310546, D210837166), 10884521551923(D200101284, D200745037). |
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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-1376-2025%22
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