Oridion Medical 1987 Ltd.: Medical Device Recall in 2025 - (Recall #: Z-1384-2025)

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, MVAI; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, MVAI100U; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVAIH; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVAIH100U; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft High Humidity, MVAIHH; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 4m/13ft Extended Duration, MVAIHL; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 4m/13ft Short-term use: Procedural/Emergency, MVAIL; Microstream Advance Air Military Sample Kit CO2 Oral-Nasal Filter Line with O2 Tubing (MVAO) and Adult-Pediatric Intubated Filter Line, High Humidity (MVAIHH) 2m/6.5ft, MVAMSK; Microstream Advance Adult Sample Kit CO2 Intubated Filter Line (MVAI) and CO2 Oral-Nasal Filter Line with O2 Connector (MVA) 2m/6.5ft, MVASK; Microstream Advance Adult-Pediatric IntubatedCO2 Filter Line 2m/6.5ft Extended Duration, ZMVAIH; Microstream Advance Adult-Pediatric IntubatedCO2 Filter Line 2m/6.5ft High Humidity, ZMVAIHH; Microstream Advance Adult-Pediatric IntubatedCO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, ZMVAI;

Class II

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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23K0520JZ, 23K0521JZ, 23L1114JZ, 23L1115JZ, 23L1116JZ, 23L1117JZ, 23L1118JZ, 23L1119JZ, 23L1120JZ, 23L1173JZ, 23L1174JZ, 23L1175JZ, 23L1176JZ, 24A0945JZ, 24A0946JZ, 24A0947JZ, 24A0948JZ, 24A0949JZ, 24B0361JZ, 24B1109JZ, 24B1110JZ, 24B1111JZ, 24B1112JZ, 24B1113JZ, 24C0298JZ, 24C0299JZ, 24C0300JZ, 24C0301JZ, 24E0252JZ, 24E0253JZ, 24E0254JZ, 24E0255JZ, 24E0257JZ, 24E0258JZ, 24E0259JZ, 24E0260JZ, 24E0261JZ, 24E0491JZ, 24G1239JZ, 24G1240JZ, 24G1241JZ, 24G1242JZ, 24G1243JZ, 24G1244JZ, 24G1245JZ, 24H1091JZ, 24H1092JZ, 24H1093JZ, 24H1094JZ, 24H1094JZ, 24H1095JZ, 24H1096JZ, 24H1097JZ, 24H1098JZ, 24I0518JZ, 24I0521JZ, 24I1067JZ, 24I1068JZ, 24I1069JZ, 24I1070JZ, 24I1071JZ, 24I1072JZ, 24I1073JZ, 24I1074JZ, 24I1075JZ, 24J1146JZ, 24J1147JZ, 24J1148JZ, 24J1149JZ, 24J1150JZ, 24J1151JZ, 24J1152JZ, 24J1153JZ, 24J1154JZ, 24J1155JZ, 24K0917JZ, 24K0918JZ, 24K0919JZ, 24K0920JZ, 24K0921JZ, 24L0926JZ, 24L0927JZ); MVAI100U/20884521761893(D201262882), 10884521761896(C201200394, C220861807, C220865392, C220974771, C221189671, C230519782, C230733059, C240104042, C240204822, C240205548, C240313617, D200100348, D200313711, D200314544, D201262882, D210206032, 20G0602JZ, 21A0818JZ, 21A0819JZ, 21A0823JZ, 21B0737JZ, 21C0184JZ, 21C0921JZ, 21K0574JZ, 21K0575JZ, 21K0576JZ, 21K0577JZ, 22A0216JZ, 22A0217JZ, 22A0218JZ, 22A0219JZ, 22A0220JZ, 22A0221JZ, 22A0222JZ, 22A0223JZ, 22A1262JZ, 22A1263JZ, 22A1264JZ, 22A1265JZ, 22A1266JZ, 22A1267JZ, 22A1268JZ, 22A1270JZ, 22A1271JZ, 22A1273JZ, 22B1199JZ, 22B1200JZ, 22B1201JZ, 22B1202JZ, 22B1203JZ, 22B1204JZ, 22B1205JZ, 22B1206JZ, 22B1207JZ, 22B1208JZ, 22B1209JZ, 22B1210JZ, 22B1211JZ, 22B1427JZ, 22B1428JZ, 22B1429JZ, 22B1430JZ, 22B1431JZ, 22B1434JZ, 22B1436JZ, 22B1440JZ, 22C0307JZ, 22C0308JZ, 22C0309JZ, 22C1711JZ, 22C1712JZ, 22C1714JZ, 22C1715JZ, 22D0621JZ, 22D0622JZ, 22D0623JZ, 22D0624JZ, 22E0323JZ, 22E0324JZ, 22E0325JZ, 22E0326JZ, 22E0327JZ, 22E0328JZ, 22E0329JZ, 22E0330JZ, 22E0335JZ, 22E0336JZ, 22E0337JZ, 22E0338JZ, 22E0339JZ, 22E0340JZ, 22E0341JZ, 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22K0378JZ, 22K0379JZ, 22K0380JZ, 22K0819JZ, 22K0820JZ, 22K0821JZ, 22K0822JZ, 22K0823JZ, 22K0824JZ, 22K0825JZ, 22K0826JZ, 22K1928JZ, 22K1929JZ, 22K1930JZ, 22K1931JZ, 22K1932JZ, 22K1933JZ, 22K1934JZ, 22K1935JZ, 22K1936JZ, 22K1937JZ, 22K1938JZ, 23B0141JZ, 23B0293JZ, 23B0294JZ, 23B0295JZ, 23B0593JZ, 23B0594JZ, 23B0595JZ, 23B0596JZ, 23B0597JZ, 23B0598JZ, 23B1258JZ, 23B1259JZ, 23B1260JZ, 23B1261JZ, 23B1262JZ, 23B1263JZ, 23B1264JZ, 23B1265JZ, 23B1266JZ, 23B1267JZ, 23B1268JZ, 23B1269JZ, 23B1270JZ, 23B1271JZ, 23B1272JZ, 23B1273JZ, 23B1274JZ, 23B1275JZ, 23D0148JZ, 23D0149JZ, 23D0150JZ, 23D0151JZ, 23D0152JZ, 23D0153JZ, 23D0154JZ, 23D0155JZ, 23D0156JZ, 23D0157JZ, 23D0158JZ, 23D0159JZ, 23E0448JZ, 23E0449JZ, 23E0450JZ, 23E0451JZ, 23E0452JZ, 23E0453JZ, 23E0454JZ, 23E0455JZ, 23E0456JZ, 23E0457JZ, 23F0209JZ, 23F0210JZ, 23F0211JZ, 23F0212JZ, 23F0213JZ, 23F0214JZ, 23F0215JZ, 23F0216JZ, 23F0217JZ, 23F0218JZ, 23F0219JZ, 23F0220JZ, 23L1113JZ, 24C0388JZ, 24C0389JZ, 24C0390JZ, 24C0391JZ, 24E0262JZ, 24E0263JZ, 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22J0150JZ, 22J0151JZ, 22J0152JZ, 22J0153JZ, 22J0854JZ, 22J0855JZ, 22J0856JZ, 22J0857JZ, 22J0858JZ, 22J0859JZ, 22J0860JZ, 22J0861JZ, 22J0862JZ, 22J0863JZ, 22J0864JZ, 22J0865JZ, 22K0839JZ, 22K0840JZ, 22K0841JZ, 22K0842JZ, 22K0843JZ, 22K0844JZ, 22K0845JZ, 22K0846JZ, 22K0847JZ, 22K0848JZ, 22K0849JZ, 22K0850JZ, 22K0851JZ, 22K0852JZ, 22K1952JZ, 22K1953JZ, 22K1954JZ, 22K1955JZ, 22K1956JZ, 22K1957JZ, 22K1958JZ, 22K1959JZ, 22L0736JZ, 22L0737JZ, 22L0738JZ, 22L0739JZ, 22L0740JZ, 22L0741JZ, 22L0742JZ, 22L0743JZ, 22L0744JZ, 22L0745JZ, 22L0746JZ, 22L0747JZ, 23A0711JZ, 23A0712JZ, 23A0713JZ, 23A0714JZ, 23A0715JZ, 23A0716JZ, 23A0717JZ, 23A0718JZ, 23A0719JZ, 23A0720JZ, 23A0721JZ, 23A0722JZ, 23A0723JZ, 23A0724JZ, 23A0725JZ, 23A0726JZ, 23A0727JZ, 23B1234JZ, 23B1235JZ, 23B1236JZ, 23B1237JZ, 23B1238JZ, 23B1239JZ, 23B1240JZ, 23D0138JZ, 23D0139JZ, 23D0140JZ, 23D0141JZ, 23D0142JZ, 23D0143JZ, 23D0144JZ, 23D0145JZ, 23D0146JZ, 23F0260JZ, 23F0261JZ, 23F0262JZ, 23F0263JZ, 23F0264JZ, 23F0265JZ, 23F0266JZ, 23F0267JZ, 23F0268JZ, 23F0269JZ, 23F0270JZ, 23F0271JZ, 23F0272JZ, 23F0273JZ, 23F0274JZ, 23G0576JZ, 23G0577JZ, 23G0578JZ, 23G0586JZ, 23G0587JZ, 23G0588JZ, 23G0589JZ, 23G0590JZ, 23H0528JZ, 23H0529JZ, 23H0530JZ, 23H0531JZ, 23H0701JZ, 23H0702JZ, 23H0703JZ, 23H0704JZ, 23H0705JZ, 23H0706JZ, 23H0707JZ, 23I0235JZ, 23I0236JZ, 23I0509JZ, 23I0510JZ, 23I0511JZ, 23I0512JZ, 23I0513JZ, 23I0665JZ, 23I0666JZ, 23I0667JZ, 23I0668JZ, 23I0669JZ, 23I0670JZ, 23I0671JZ, 23I0672JZ, 23I0673JZ, 23I0674JZ, 23I0675JZ, 23J0377JZ, 23J0378JZ, 23J0379JZ, 23J0380JZ, 23J0381JZ, 23J0382JZ, 23J0383JZ, 23J0384JZ, 23J0385JZ, 23J0386JZ, 23J0387JZ, 23K0510JZ, 23K0511JZ, 23K0512JZ, 23K0513JZ, 23K0514JZ, 23K0515JZ, 23K0516JZ, 23K0517JZ, 23K1194JZ, 23L0326JZ, 23L0327JZ, 23L0328JZ, 24A0938JZ, 24A0939JZ, 24A0940JZ, 24A0941JZ, 24A0942JZ, 24A0943JZ, 24A0944JZ, 24B0383JZ, 24B0388JZ, 24B0389JZ, 24B0497JZ, 24B0498JZ, 24B0499JZ, 24B1102JZ, 24B1103JZ, 24B1104JZ, 24B1105JZ, 24B1106JZ, 24B1107JZ, 24B1108JZ, 24E0265JZ, 24E0522JZ, 24E0523JZ, 24E0524JZ, 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.

Voluntary: Firm initiated