FDAFDA · Food and drugs·Recall number 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
Published March 26, 2025 · Recall initiated: February 17, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Oridion Medical 1987 Ltd.
- Distributor
- 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.
- Lot
- 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)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Israel
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.