Microstream Instructions for Use recalled by Oridion Medical 1987

Yes. Oridion Medical 1987 recalled Microstream Instructions for Use on 17 Feb 2025. The recall is Class II and its status is Ongoing. Recall number Z-1384-2025.

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.

Part Number and Revision - REF/UDI-DI(Lot): PT00156254 Rev A - MVAI/20884521761886(C220756034, C221087559, C221192968, C230316355, C230519976, C230837238, C240522589, C240628663, C240729559, D191172616, D201158974, D210312139, D210622030, D210946062, D211154042), 10884521761889(C201200384, C210848192, C210961521, C211092998, C220210315, C220430764, C220538972, C220756034, C220974765, C221087559, C221192968, C230208561, C230314111, C230316355, C230519976, C230523453, C230837238, C231158548, C231158549, C231263415, C240100219, C240522589, C240628663, C240729559, D191172616, D201158974, D201262172, D201262870, D210312139, D210622030, D210946062, D211154042, D220104966, 20G0601JZ, 21A0820JZ, 21A0820JZ, 21A0821JZ, 21A0821JZ, 21A0822JZ, 21C0922JZ, 21G0025JZ, 21G0026JZ, 21G0027JZ, 21G0031JZ, 21G0396JZ, 21G0397JZ, 21G0398JZ, 21H0057JZ, 21H0058JZ, 21H0059JZ, 21H0060JZ, 21H0061JZ, 21H0978JZ, 21H0979JZ, 21H0980JZ, 21H0981JZ, 21H0982JZ, 21I0497JZ, 21I0639JZ, 21I0640JZ, 21J0125JZ, 21J0126JZ, 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24E0525JZ, 24E0526JZ, 24E1481JZ, 24E1482JZ, 24E1483JZ, 24E1484JZ, 24E1485JZ, 24E1486JZ, 24E1487JZ, 24E1488JZ, 24G0510JZ, 24G0511JZ, 24G0512JZ, 24G0513JZ, 24G0514JZ, 24G0515JZ, 24G0516JZ, 24G0517JZ, 24G0518JZ, 24G0519JZ, 24G0520JZ, 24G1251JZ, 24G1252JZ, 24H1079JZ, 24H1080JZ, 24H1081JZ, 24H1083JZ, 24H1084JZ, 24H1085JZ, 24H1086JZ, 24H1087JZ, 24H1088JZ, 24H1089JZ, 24H1090JZ, 24I1056JZ, 24I1057JZ, 24I1058JZ, 24I1059JZ, 24I1060JZ, 24I1061JZ, 24I1062JZ, 24I1063JZ, 24I1064JZ, 24I1065JZ, 24I1076JZ, 24I1077JZ, 24I1078JZ, 24I1079JZ, 24I1080JZ, 24I1081JZ, 24I1082JZ, 24J1144JZ, 24J1145JZ, 24K0906JZ, 24K0907JZ, 24K0908JZ, 24K0909JZ, 24K0910JZ, 24K0911JZ, 24K0912JZ, 24K0913JZ, 24K0914JZ, 24K0915JZ, 24K0916JZ, 24L0928JZ, 24L0929JZ, 24L0930JZ, 24L0931JZ, 24L0932JZ, 24L0933JZ, 24L0934JZ, 24L0935JZ, 24L0936JZ, 24L0937JZ, 24L0938JZ, 25A0989JZ, 25A0990JZ, 25A0991JZ, 25A0992JZ, 25A0993JZ, 25A0994JZ), 20884521761916(21A0815JZ, 21J1171JZ, 21J1172JZ, 22B1184JZ, 22B1186JZ, 22D0252JZ, 22D0253JZ, 22D0254JZ, 22D0319JZ, 22D0321JZ, 22D0322JZ, 22D0323JZ, 22D0324JZ, 22D0325JZ, 22E1463JZ, 22E1465JZ, 22E1466JZ, 22E1474JZ, 22G0075JZ, 22G0077JZ, 22G0079JZ, 22G0081JZ, 22G0082JZ, 22H0170JZ, 22H0176JZ, 22H0179JZ, 22H0655JZ, 22J0861JZ, 22K0843JZ, 22K0851JZ, 23A0716JZ, 23A0719JZ, 23A0722JZ, 23B1234JZ, 23D0146JZ, 23F0266JZ, 23K0514JZ, 24E1481JZ, 24E1484JZ, 24J1144JZ); MVAIH100U/10884521761926(C210415654, C220974779, C220975952, C221085124, C230211848, C230522202, C230733067, C231159731, C240104050, C240206308, C240414492, D191282624, D201158948, D201262132, D201262846, D210205987, D210517010, D210725654, 21A0816JZ, 21A0817JZ, 21G0698JZ, 21K0566JZ, 21K0567JZ, 21K0568JZ, 22A0211JZ, 22A0212JZ, 22A0213JZ, 22A1276JZ, 22A1277JZ, 22A1278JZ, 22B1415JZ, 22B1416JZ, 22B1417JZ, 22B1418JZ, 22B1419JZ, 22B1420JZ, 22B1421JZ, 22B1422JZ, 22B1423JZ, 22B1424JZ, 22B1425JZ, 22B1426JZ, 22D0336JZ, 22D0337JZ, 22D0338JZ, 22D0339JZ, 22D0683JZ, 22E0308JZ, 22E0309JZ, 22E0310JZ, 22E0311JZ, 22E0312JZ, 22E0313JZ, 22E0314JZ, 22E0315JZ, 22E0316JZ, 22E0317JZ, 22E0318JZ, 22E0319JZ, 22E1478JZ, 22E1479JZ, 22E1480JZ, 22E1481JZ, 22E1482JZ, 22E1483JZ, 22E1484JZ, 22E1485JZ, 22E1486JZ, 22E1487JZ, 22E1488JZ, 22E1489JZ, 22K1146JZ, 22K1147JZ, 22K1148JZ, 22K1149JZ, 22K1150JZ, 22K1151JZ, 22K1152JZ, 22K1153JZ, 22K1154JZ, 22K1155JZ, 22K1156JZ, 22L0748JZ, 22L0749JZ, 22L0750JZ, 22L0751JZ, 22L0752JZ, 22L0753JZ, 22L0754JZ, 22L0755JZ, 22L0756JZ, 22L0757JZ, 22L0758JZ, 22L0759JZ, 23B0296JZ, 23B1246JZ, 23B1247JZ, 23B1248JZ, 23B1249JZ, 23B1250JZ, 23B1251JZ, 23B1252JZ, 23B1253JZ, 23B1254JZ, 23B1255JZ, 23B1256JZ, 23B1257JZ, 23C1348JZ, 23C1349JZ, 23C1350JZ, 23C1351JZ, 23C1352JZ, 23C1353JZ, 23D0122JZ, 23D0123JZ); MVAIHH/10884521762008(C210415652, C210736858, C211102393, C220103628, C220210317, C220216550, C220321225, C220540987, C220540991, C220649323, C220751604, C220858507, C220865635, C220974775, C221193706, C230103886, C230521272, C230627862, C230943371, C230943373, C231156185, C240208658, C240311963, C240417208, C240521264, C240624405, C240729894, C240731161, C240832775, C240935709, C241100832, D181137005, D181137006, D181137007, D201158925, D211157164, D220100665, D220632504, D220632506, D220635655, D220944770); MVAIHL/10884521761933(C210314318, C210736813, C210961351, C211195913, C211209800, C220101632, C220210071, C220320712, C220540828, C220540830, C220540833, C220642990, C220649104, C220751446, C220861855, C220974777, C221087383, C230103644, C230211797, C230313078, C230519787, C230519980, C230520042, C230523261, C230625415, C231051553, C240103213, C240207696, C240313626, C240520095, C240521087, C240626636, C240731163, C240832777, C241038133, D191172608, D201158964, D201262155, D201262156, D201263401, D210311397, D210517014, D210837906, D210946049, D220317742); MVAIL/20884521761909(C230211736, C240519169, C240521074, D191172604, D210104124), 10884521761902(C201100339, C201100340, C201100341, C201200367, C210207222, C210314241, C210736197, C210952345, C211063328, C211101173, C211206566, C220103206, C220103207, C220210008, C220430747, C220430749, C220538967, C220754686, C220974769, C221295517, C230103847, C230104972, C230211736, C230417429, C230519780, C230627662, C230730682, C230733056, C230943213, C230944414, C231048757, C231157389, C231158559, C231158560, C231158562, C240100227, C240519169, C240521074, C240628668, C240933083, C241037680, D191172604, D201158960, D201261418, D210104124, D210517012, D210725658, D210946047, D211153870, D211157186, D211157912, D220207963, D220318424, D220529189, D220635679); MVAMSK/10884521783997(C211085718, C220213294, C220754930, C220971007, C221082004, C230206366, C230624523); MVASK/10884521783980(C210525106, C211085609, C220863141, C220969758, C221293902, C221294087, D200432255, D211156488, D220104893, D220104894); ZMVAIH/20884521762258(M230500059); ZMVAIHH/20884521762265(M240100079); ZMVAI/20884521771762(M221200053, M230500056)

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.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.