Reported Mar 26, 2025 · Ongoing
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated…
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 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
- Lot codes and dates
- 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, C220863127, C220974781, C221191770, C221295623, C230211851, C230418533, C230519983, C231159734, C240522133, C240728993, C241100393, C241100395, D200313724, D201159036, D210837943, D211157228, D220102672), 20884521762012(C220108515, C220863127, C230519983); MVIIHL/10884521761995(C210415658, C210736860, C211070955, C211101307, C211213581, C220646858, C220861928, C220866691, C220974783, C221081920, C221193708, C230206266, C230313137, C230733071, C231159737, C240832779, D191282990, D201159038, D210837945); ZMVIIH/10884521762275(M221200054, M230700062)
- Amount recalled
- 704423
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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