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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1385-2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream 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

Publicado el 26 de marzo de 2025 · Inicio del retiro: 17 de febrero de 2025

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Oridion Medical 1987 Ltd.
Distribuidor
Worldwide - US Nationwide distribution including in the states of TX, OH, FL, CO, IL, CA, MD, PA, VA, WI, IN, MI, NY, GA, OR, SC, NC, PR, AZ, KY, AR, TN, MO, DE, MA, MS, UT, DC, NE, IA, WV, NJ, KS, LA, WA, HI, MN, AL, ME, RI, OK, MT, ID, CT, NH, AK, NV, SD, WY, ND, NM and the countries of Algeria, Andorra, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, Northern Ireland, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Virgin Islands, U.S.
Lote
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)
Clasificación de riesgo
Class II
Área (FDA)
device
País
Israel

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