Reported Mar 26, 2025 · Ongoing
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H…
Oridion Medical 1987 Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Oridion Medical 1987 Ltd. · Har Hotzvim Industrial Park Box 45025 · Jerusalem, N/A · N/A
Is this the product you have?
- Microstream Instructions for Use and Part Number used with - Product Description
- REFFilterLine 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
- Lot codes and dates
- 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)
- Amount recalled
- 318292
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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