Reported Mar 26, 2025 · Ongoing
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant…
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
- REFMicrostream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVIIH
- Lot codes and dates
- Part
- Number and Revision - REF/UDI-DI(Lot)PT00134354 Rev A- QMVIIH/10884521762374(C210314316, C211085494)
- Amount recalled
- 350
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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