Reported Mar 26, 2025 · Ongoing
Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling…
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
- REFAirway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989; Omnistream CO2 Sampling Line X25, 010991
- Lot codes and dates
- Part
- Number and Revision - REF/UDI-DI(Lot)01158 Rev E PT00156356 - 010989/20884521762159(C220975945), 20884521552033(D200320259), 10884521762152(C210845590, C220975945, C221193754); 010991/10884521554092(D200638964, D210204584)
- Amount recalled
- 7076
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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