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;
This recall is currently active, issued March 17, 2025. It was issued by Oridion Medical 1987 Ltd. Har Hotzvim Industrial.
- Recall Initiated
- February 17, 2025
- Posted
- March 17, 2025
- Recall Number
- Z-1384-2025
- Quantity
- 8435772
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
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 / Code Info
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, 21J0127JZ, 21J0128JZ, 21J0129JZ, 21J0130JZ, 21J0131JZ, 21J0164JZ, 21J1242JZ, 21J1243JZ, 21J1244JZ, 21J1245JZ, 21J1246JZ, 21J1247JZ, 21J1248JZ, 21J1249JZ, 21J1250JZ, 21J1251JZ, 21J1252JZ, 21K0570JZ, 21K0571JZ, 21K0572JZ, 21K0573JZ, 21K0579JZ, 21K0580JZ, 21K0581JZ, 21K0582JZ, 21K0583JZ, 21K0584JZ, 21K0585JZ, 21K0586JZ, 21K0587JZ, 21K0588JZ, 21K0589JZ, 21L0876JZ, 21L0877JZ, 21L0878JZ, 21L0879JZ, 21L0880JZ, 22A0225JZ, 22A0226JZ, 22A0227JZ, 22A0228JZ, 22A0229JZ, 22A0230JZ, 22A0231JZ, 22A0232JZ, 22A1092JZ, 22A1093JZ, 22A1250JZ, 22A1251JZ, 22A1252JZ, 22A1253JZ, 22A1254JZ, 22A1255JZ, 22A1257JZ, 22A1258JZ, 22A1259JZ, 22A1260JZ, 22A1261JZ, 22B0323JZ, 22B0324JZ, 22B0325JZ, 22B0326JZ, 22B0327JZ, 22B0328JZ, 22B0329JZ, 22B0330JZ, 22B0331JZ, 22C0577JZ, 22C0578JZ, 22C1713JZ, 22C1716JZ, 22D0248JZ, 22D0249JZ, 22D0250JZ, 22D0306JZ, 22D0307JZ, 22D0308JZ, 22D0309JZ, 22D0681JZ, 22D0682JZ, 22E0320JZ, 22E0321JZ, 22E0322JZ, 22E0344JZ, 22E0345JZ, 22E0346JZ, 22E0347JZ, 22E0348JZ, 22E0349JZ, 22E1490JZ, 22E1491JZ, 22E1492JZ, 22E1493JZ, 22E1494JZ, 22E1495JZ, 22E1496JZ, 22E1497JZ, 22E1498JZ, 22E1499JZ, 22E1499JZ, 22E1500JZ, 22E1501JZ, 22E1502JZ, 22E1503JZ, 22E1504JZ, 22E1504JZ, 22E1628JZ, 22E1629JZ, 22E1630JZ, 22G0092JZ, 22G0092JZ, 22G0093JZ, 22G0094JZ, 22G0095JZ, 22G0095JZ, 22G0096JZ, 22G0097JZ, 22G0097JZ, 22G0098JZ, 22G0099JZ, 22G0100JZ, 22G0101JZ, 22G0102JZ, 22G0102JZ, 22G0121JZ, 22G0949JZ, 22G0950JZ, 22G0989JZ, 22I0466JZ, 22I0467JZ, 22I0468JZ, 22I0469JZ, 22I0470JZ, 22I0471JZ, 22I0472JZ, 22I0472JZ, 22I0473JZ, 22I0475JZ, 22I0477JZ, 22I0478JZ, 22I0479JZ, 22I0479JZ, 22I0480JZ, 22I0481JZ, 22I0482JZ, 22I0501JZ, 22J0471JZ, 22J0472JZ, 22J0473JZ, 22J0474JZ, 22J0475JZ, 22J0476JZ, 22J0477JZ, 22J0478JZ, 22J0479JZ, 22J0480JZ, 22J0481JZ, 22J0482JZ, 22J0846JZ, 22J0847JZ, 22J0848JZ, 22J0849JZ, 22J0850JZ, 22J0851JZ, 22K0827JZ, 22K0828JZ, 22K0829JZ, 22K0830JZ, 22K0831JZ, 22K0832JZ, 22K0833JZ, 22K0834JZ, 22K0835JZ, 22K0836JZ, 22K0837JZ, 22K0838JZ, 22K1939JZ, 22K1940JZ, 22K1940JZ, 22K1941JZ, 22K1942JZ, 22K1943JZ, 22K1944JZ, 22K1945JZ, 22K1946JZ, 22K1947JZ, 22K1948JZ, 22K1949JZ, 22K1950JZ, 22K1951JZ, 22L0719JZ, 22L0720JZ, 22L0721JZ, 22L0722JZ, 22L0723JZ, 22L0724JZ, 22L0725JZ, 22L0726JZ, 22L0727JZ, 22L0728JZ, 22L0729JZ, 22L0730JZ, 22L0731JZ, 22L0732JZ, 22L0733JZ, 22L0734JZ, 22L0735JZ, 23A0696JZ, 23A0697JZ, 23A0698JZ, 23A0699JZ, 23A0700JZ, 23A0701JZ, 23A0702JZ, 23A0703JZ, 23A0704JZ, 23A0705JZ, 23A0706JZ, 23A0707JZ, 23B1241JZ, 23B1242JZ, 23B1243JZ, 23B1244JZ, 23D0126JZ, 23D0126JZ, 23D0127JZ, 23D0127JZ, 23D0128JZ, 23D0129JZ, 23D0130JZ, 23D0131JZ, 23D0132JZ, 23D0133JZ, 23D0134JZ, 23D0135JZ, 23D0136JZ, 23D0137JZ, 23F0227JZ, 23F0228JZ, 23F0229JZ, 23F0230JZ, 23F0231JZ, 23F0232JZ, 23F0233JZ, 23F0234JZ, 23F0235JZ, 23F0236JZ, 23F0237JZ, 23F0238JZ, 23F0239JZ, 23F0240JZ, 23F0241JZ, 23F0242JZ, 23F0243JZ, 23F0244JZ, 23F0245JZ, 23F0246JZ, 23H0004JZ, 23H0005JZ, 23H0708JZ, 23H0708JZ, 23I0237JZ, 23I0238JZ, 23I0734JZ, 23I0735JZ, 23I0736JZ, 23I0737JZ, 23I0738JZ, 23J0388JZ, 23J0389JZ, 23J0390JZ, 23K0518JZ, 23K0519JZ, 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, 22E0343JZ, 22G0103JZ, 22G0104JZ, 22G0105JZ, 22G0106JZ, 22G0107JZ, 22G0108JZ, 22G0109JZ, 22G0110JZ, 22G0111JZ, 22G0112JZ, 22G0113JZ, 22G0114JZ, 22G0115JZ, 22G0116JZ, 22G0117JZ, 22G0118JZ, 22G0119JZ, 22G0120JZ, 22G0951JZ, 22G0952JZ, 22G0954JZ, 22H0181JZ, 22H0182JZ, 22H0183JZ, 22H0184JZ, 22H0185JZ, 22H0186JZ, 22H0187JZ, 22H0188JZ, 22H0189JZ, 22H0190JZ, 22H0191JZ, 22H0192JZ, 22H0193JZ, 22H0194JZ, 22H0195JZ, 22H0196JZ, 22H0197JZ, 22H0198JZ, 22H0199JZ, 22H0200JZ, 22H0201JZ, 22H0202JZ, 22H0203JZ, 22H0204JZ, 22H1258JZ, 22H1259JZ, 22H1260JZ, 22H1261JZ, 22H1262JZ, 22H1263JZ, 22H1264JZ, 22H1265JZ, 22H1266JZ, 22H1267JZ, 22H1268JZ, 22H1269JZ, 22H1270JZ, 22I0370JZ, 22I0371JZ, 22I0372JZ, 22I0458JZ, 22I0461JZ, 22I0462JZ, 22I0483JZ, 22I0484JZ, 22I0485JZ, 22I0486JZ, 22I0487JZ, 22I0488JZ, 22I0489JZ, 22I0490JZ, 22I0491JZ, 22I0492JZ, 22I0493JZ, 22I0494JZ, 22I0495JZ, 22J0866JZ, 22J0867JZ, 22J0868JZ, 22J0869JZ, 22J0870JZ, 22J0871JZ, 22J0872JZ, 22J0873JZ, 22K0373JZ, 22K0374JZ, 22K0375JZ, 22K0376JZ, 22K0377JZ, 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, 24E0264JZ, 24E1489JZ, 24E1490JZ, 24E1491JZ, 24E1492JZ, 24E1493JZ, 24E1494JZ, 24E1495JZ, 24E1496JZ, 24E1497JZ, 24E1498JZ, 24E1499JZ, 24E1500JZ, 24E1501JZ, 24E1502JZ, 24E1503JZ, 24E1504JZ, 24E1505JZ, 24E1506JZ, 24F0582JZ, 24F0583JZ, 24E1586JZ, 24E1588JZ); MVAIH/10884521761919(C210314324, C211072071, C211195928, C220649131, C220866640, C220974767, C221192805, C221295586, C230103669, C230521102, C230523237, C230627658, C230733048, C230940144, C230944408, C231157382, C240522592, C240728987, C240731157, C240832565, D191172570, D201158944, D201261393, D201262844, D210205985, D210311389, D210415747, D210519534, D210837204, D210940202, D210940984, D210942597, D210944281, D211046881, 20G0603JZ, 21A0812JZ, 21A0813JZ, 21A0814JZ, 21A0815JZ, 21C0185JZ, 21C0186JZ, 21C0920JZ, 21G0529JZ, 21J0110JZ, 21J0111JZ, 21J0112JZ, 21J0113JZ, 21J0114JZ, 21J1168JZ, 21J1169JZ, 21J1170JZ, 21J1171JZ, 21J1172JZ, 21K0565JZ, 21K0578JZ, 22A0204JZ, 22A0205JZ, 22A0206JZ, 22A0224JZ, 22A1081JZ, 22A1229JZ, 22A1230JZ, 22A1231JZ, 22A1233JZ, 22A1234JZ, 22A1236JZ, 22A1237JZ, 22B1175JZ, 22B1176JZ, 22B1177JZ, 22B1178JZ, 22B1184JZ, 22B1186JZ, 22C0312JZ, 22D0247JZ, 22D0251JZ, 22D0252JZ, 22D0253JZ, 22D0254JZ, 22D0314JZ, 22D0315JZ, 22D0316JZ, 22D0317JZ, 22D0318JZ, 22D0319JZ, 22D0320JZ, 22D0321JZ, 22D0322JZ, 22D0323JZ, 22D0324JZ, 22D0325JZ, 22D0326JZ, 22D0327JZ, 22D0328JZ, 22D0329JZ, 22E0307JZ, 22E1458JZ, 22E1459JZ, 22E1460JZ, 22E1461JZ, 22E1462JZ, 22E1463JZ, 22E1464JZ, 22E1465JZ, 22E1466JZ, 22E1467JZ, 22E1468JZ, 22E1469JZ, 22E1470JZ, 22E1471JZ, 22E1472JZ, 22E1473JZ, 22E1474JZ, 22E1475JZ, 22E1476JZ, 22E1477JZ, 22F1180JZ, 22G0075JZ, 22G0076JZ, 22G0077JZ, 22G0078JZ, 22G0079JZ, 22G0080JZ, 22G0081JZ, 22G0082JZ, 22G0083JZ, 22G0084JZ, 22H0168JZ, 22H0169JZ, 22H0170JZ, 22H0171JZ, 22H0172JZ, 22H0173JZ, 22H0174JZ, 22H0175JZ, 22H0176JZ, 22H0177JZ, 22H0178JZ, 22H0179JZ, 22H0653JZ, 22H0654JZ, 22H0655JZ, 22H0656JZ, 22H0657JZ, 22H0658JZ, 22H0659JZ, 22H0660JZ, 22I0263JZ, 22I0264JZ, 22I0265JZ, 22I0266JZ, 22I0267JZ, 22I0268JZ, 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)
Root Cause
Labeling design
Action Taken
On 2/17/2025, correction notices were mailed to Risk Manager, Director of Respiratory Care, Director of Anesthesiology who were informed of the following: In September 2025, the firm will issue an update to the Instructions for Use (IFUs) for the The following IFU's: 01158, PT00156355, PT00156254, PT00156250 stating: Adverse events associated with attaching and detaching the airway adapter from the breathing circuit are listed in descending order of severity: unintended extubation, respiratory failure, hypoxia, low oxygen saturation, aspiration/inhalation and delay to treatment. Any serious incident related to device use that may occur should be reported immediately to the manufacturer, the local competent authority, and any other regulators as required. Pass on and post this notice for all those who need to be aware within your organization and to any organization where the affected product has been transferred or distributed. Complete and return the Customer Confirmation Form to rs.gmbmitgfca@medtronic.com Adverse reactions or quality problems experienced with this product should be reported to the firm's Quality Assurance at 800-255-6774 option 1, then option 1. If you have questions contact the firm's Customer Service at 800-962-9888, Option 2. On 5/13/2025, additional correction notices identifying additional affected devices were mailed to additional customers.