Device product
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 007737; MICROSTREAM FilterLine Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter, 007768; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 010579; MICROSTREAM FilterLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 010580; MICROSTREAM VitaLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for High Ambient Humidity X25, 010787; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 015016; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 015021; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, XS04620; MICROSTREAM FilterLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, XS04624.
Z-1377-2025
Product summary
- Event
- Event 96309
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5125183
- Official record key
device-enforcement:Z-1377-2025
Official wording
Reason: 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.
Code information: Part Number and Revision - REF/UDI-DI(Lot): MQ04616 Rev N - 007737/20884521551784(C210417261, C211105048, C211195967, C220103407, D191067290, D191176261, D191280252, D191283149, D200101321, D200424621, D200430274, D200432060, D200434623, D200537510, D200949677, D200952336, D201261089, D210101553, D210102181, D210204904, D210310618, D210310620, D210516971, D210519861, D210729258); 007768/10884521554023(C210417263, C210521895, C210521896, C210521897, C210957019, C211195969, C211206703, C211213565, D191067432, D191171903, D191177363, D191280436, D191283316, D200100401, D200322342, D200426869, D200536227, D200538142, D200640949, D200744614, D200744615, D200950363, D201055939, D201260696, D210101022, D210103470, D210104022, D210310522, D210726720, D211046826); 010579/10884521551985(D191171913, D200100405, D200101489, D200640405, D200744634,19J0743JZ, 19J0744JZ, 19K0492JZ, 19K0493JZ, 19K0836JZ, 20A0041JZ, 20A0042JZ, 20A0043JZ, 20A0044JZ, 20A0667JZ, 20A0668JZ, 20A0669JZ, 20A0670JZ, 20A0671JZ, 20B0176JZ, 20B0177JZ, 20B0664JZ, 20B0665JZ, 20B0666JZ, 20B0667JZ, 20B0668JZ, 20B0669JZ, 20B0670JZ, 20B0671JZ, 20B0672JZ, 20B0673JZ, 20B0674JZ, 20B0675JZ, 20B0676JZ, 20C0658JZ, 20C0659JZ, 20C0660JZ, 20C0661JZ, 20D0106JZ, 20D0107JZ, 20D0108JZ, 20E0222JZ, 20E0799JZ, 20E0800JZ, 20E0801JZ, 20E0802JZ, 20E0803JZ, 20E0804JZ, 20G0032JZ, 20G0033JZ, 20G0035JZ, 20G0479JZ, 20G0480JZ, 20G0481JZ, 20G0482JZ, 20G0486JZ, 20G0839JZ, 20G0840JZ, 20G0881JZ, 20G0882JZ, 20H0325JZ, 20H0326JZ, 20H0327JZ, 20H0328JZ, 20H0587JZ, 20H0588JZ, 20H0854JZ, 20H0855JZ, 20H0856JZ, 20H0857JZ, 20H0858JZ, 20H0859JZ, 20H0860JZ, 20H0861JZ, 20I0728JZ, 20I0858JZ, 20I0859JZ, 20I0860JZ, 20I0861JZ, 20I0862JZ, 20I0863JZ, 20I0864JZ, 20I0865JZ, 20J0882JZ, 20J0885JZ, 20J0886JZ, 20J0887JZ, 20J0888JZ, 20J0889JZ, 20J0912JZ, 20J0913JZ, 20K0110JZ, 20K0424JZ, 20K0425JZ, 20K0582JZ, 20K0583JZ, 20K0584JZ, 20K0585JZ, 20L0141JZ, 20L0142JZ, 20L0143JZ, 20L0144JZ, 20L0503JZ, 20L0504JZ, 20L0505JZ, 21A0677JZ, 21A0678JZ, 21A0679JZ, 21B0258JZ, 21B0259JZ, 21B0776JZ, 21B0777JZ, 21C0164JZ, 21C0165JZ, 21C0166JZ, 21C0167JZ, 21D0186JZ, 21D0192JZ, 21E0056JZ, 21E0057JZ, 21E1381JZ, 21E1382JZ, 21E1383JZ, 21E1384JZ, 21E1385JZ, 21E1386JZ, 21E1387JZ, 21G0380JZ, 21G0381JZ, 21G0382JZ, 21G0383JZ, 21G0963JZ, 21G0964JZ, 21H0044JZ, 21H0045JZ, 21H0601JZ, 21H0602JZ, 21H0603JZ, 21H0604JZ, 21H0740JZ, 21H1069JZ, 21H1070JZ, 21H1071JZ, 21H1072JZ, 21H1073JZ, 21H1074JZ, 21H1075JZ, 21H1076JZ, 21H1077JZ, 21H1078JZ, 21H1080JZ, 21H1081JZ, 21I0523JZ, 21I0524JZ, 21I0684JZ, 21I0685JZ, 21J0105JZ, 21J0106JZ, 21J0107JZ, 21J0108JZ, 21J1164JZ, 21J1165JZ, 21J1166JZ, 21J1167JZ, 21K0557JZ, 21K0558JZ, 21K0559JZ, 21K0560JZ, 21K0561JZ, 21K0562JZ), A8845215519803(19K0297JZ, 19K0298JZ, 19K0487JZ, 19K0488JZ, 19K0489JZ, 19K0490JZ, 19K0491JZ, 19K0492JZ), 10884521551992(19K0024JZ, 20B0968JZ, 20C0394JZ, 20C0927JZ), 009865(19J0754JZ, 19K0024JZ); 010580/10884521551992(D191171665, D191278710, D191283121, D200100759, D200314310, D200434507, 19K0494JZ, 19K0495JZ, 19K0496JZ, 20A0045JZ, 20A0046JZ, 20A0672JZ, 20A0674JZ, 20A0784JZ, 20B0678JZ, 20B0679JZ, 20C0257JZ, 20C0258JZ, 20C0259JZ, 20C0260JZ, 20D0594JZ, 20D0595JZ, 20D0596JZ, 20E0258JZ, 20E0259JZ, 20E0260JZ, 20E0805JZ, 20E0806JZ, 20G0036JZ, 20G0037JZ, 20G0038JZ, 20H0863JZ, 20H0864JZ, 20H0865JZ, 20H0866JZ, 20I0866JZ, 20I0867JZ, 20J0890JZ, 20J0891JZ, 20J0892JZ, 20J0893JZ, 20K0586JZ, 20K0587JZ, 20K0588JZ, 20K0589JZ, 20L0507JZ, 20L0508JZ, 20L0509JZ, 20L0510JZ, 21C0187JZ, 21D0188JZ, 21D0189JZ, 21E0058JZ, 21E0059JZ, 21E0060JZ, 21E1379JZ, 21E1380JZ, 21G0385JZ, 21H0046JZ, 21H0047JZ, 21H0048JZ, 21H0049JZ, 21H0799JZ, 21H0800JZ, 21H0963JZ, 21H0964JZ, 21H1082JZ, 21H1083JZ, 21H1084JZ, 21H1085JZ), 10884521184770(D200314310); 010787/10884521554085(C210417265, C210957021, C211206708, D191176289, D191283153, D200101678, D200314401, D200424959, D200430313, D200639040, D200745120, D201055980, D201260748, D210103530, D210308662, D210311353, D210725622, D220102567, D220318806), 10884521552029(D200101678); 015016/10884521552296(S2003151); 015021/10884521552340(S1911041, S2002041, S2004161, S2104131); XS04620/30884521551989(D191067442, D191171912, D191278987, D191282749, D200314632, D200314633, D200316318, D200322078, D200639833, D200640404, D200745789, D200950023, D210103526, D210205943, D210414402, D210519494, D210725617, D210940184, D211153824, D211266886, 19J0745JZ, 19J0746JZ, 19J0747JZ, 19J0748JZ, 19J0750JZ, 19K0497JZ, 19K0498JZ, 19K0499JZ, 19K0500JZ, 19K0501JZ, 19K0502JZ, 19K0503JZ, 20A0047JZ, 20A0048JZ, 20A0049JZ, 20A0675JZ, 20A0676JZ, 20A0678JZ, 20A0679JZ, 20B0687JZ, 20C0669JZ, 20C0670JZ, 20C0671JZ, 20C0672JZ, 20C0673JZ, 20D0597JZ, 20D0598JZ, 20D0599JZ, 20E0807JZ, 20E0808JZ, 20E0809JZ, 20E0810JZ, 20E0812JZ, 20G0039JZ, 20G0040JZ, 20G0041JZ, 20G0483JZ, 20G0484JZ, 20G0485JZ, 20G0848JZ, 20G0849JZ, 20G1253JZ, 20G1254JZ, 20G1255JZ, 20G1256JZ, 20H0867JZ, 20H0868JZ, 20H0869JZ, 20H0870JZ, 20H0871JZ, 20H0872JZ, 20H0875JZ, 20H0876JZ, 20H0877JZ, 20I0868JZ, 20I0869JZ, 20I0870JZ, 20I0871JZ, 20I0872JZ, 20I0873JZ, 20K0591JZ, 20K0592JZ, 20K0593JZ, 20K0594JZ, 20L0683JZ, 21A0805JZ, 21B0664JZ, 21B0665JZ, 21B0707JZ, 21B0733JZ, 21C0178JZ, 21C0179JZ, 21C0180JZ, 21C0181JZ, 21C0182JZ, 21C0183JZ, 21D0193JZ, 21D0194JZ, 21D0195JZ, 21D0196JZ, 21D0197JZ, 21D0198JZ, 21E0061JZ, 21E0062JZ, 21E0063JZ, 21E0064JZ, 21E0065JZ, 21E1388JZ, 21E1389JZ, 21E1390JZ, 21E1391JZ, 21E1392JZ, 21F0555JZ, 21F0556JZ, 21G0386JZ, 21G0387JZ, 21G0388JZ, 21H0050JZ, 21H0051JZ, 21H0052JZ, 21H0053JZ, 21H0054JZ, 21H1086JZ, 21H1088JZ, 21I0496JZ, 21I0624JZ, 21I0626JZ, 21J0119JZ, 21J0120JZ, 21J0121JZ, 21J0122JZ, 21J1173JZ, 21J1174JZ, 21J1175JZ, 21J1176JZ, 21J1177JZ, 22A1239JZ, 22A1240JZ), 20884521551982(D191067442, D200314632, D200316318, D200640404), A8845215519803(19K0026JZ, 19L0439JZ, 20A0730JZ, 20A0731JZ, 20A0732JZ, 20A0733JZ, 20A0734JZ, 20A0735JZ, 20A0736JZ, 20B0253JZ, 20B0254JZ, 20B0255JZ, 20B0256JZ, 20B0257JZ, 20B0462JZ, 20B0696JZ, 20B0697JZ, 20B0699JZ, 20B0701JZ, 20B0702JZ, 20B0703JZ, 20B0705JZ, 20B0707JZ, 20B0708JZ, 20B0709JZ, 20B0711JZ, 20B0713JZ, 20C0395JZ, 20C0710JZ, 20D0601JZ, 20D0602JZ, 20D0603JZ, 20E0813JZ, 20E0814JZ, 20E0815JZ, 20E0816JZ, 20E0817JZ, 20E0818JZ, 20G0051JZ, 20G0052JZ, 20G0053JZ, 20G0054JZ, 20K0604JZ, 20L0720JZ, 20L0721JZ, 20L0722JZ, 20L0723JZ, 20L0724JZ, 20L0725JZ, 20L0726JZ, 20L0727JZ, 20L0728JZ, 20L0729JZ, 20L0730JZ, 21A0810JZ, 21A0811JZ, 21A0854JZ, 21A0855JZ, 21A0856JZ, 21C0161JZ, 21C0162JZ, 21D0857JZ), XS04661(19J0756JZ, 19K0025JZ); XS04624/30884521551996(D191064978, D191171664, D191278708, D191280200, D200314309, D200315927, D200320245, D200320251, D200639583, D200640190, D200742223, D200745614, D200949419, D201159534, D201262019, D201263314, D210205179, D210205180, D210307270, D210310549, D210311284, D210620754, D210728940, D220946384, 19J0521JZ, 19J0751JZ, 19J0752JZ, 19J0753JZ, 19K0504JZ, 19K0505JZ, 19K0506JZ, 19K0507JZ, 19K0508JZ, 19K0837JZ, 20A0050JZ, 20A0051JZ, 20A0052JZ, 20A0680JZ, 20A0681JZ, 20A0682JZ, 20A0683JZ, 20B0690JZ, 20B0692JZ, 20C0196JZ, 20C0197JZ, 20C0233JZ, 20C0234JZ, 20C0413JZ, 20C0414JZ, 20C0415JZ, 20C0416JZ, 20C0417JZ, 20C0418JZ, 20C0663JZ, 20C0664JZ, 20C0665JZ, 20C0667JZ, 20C0668JZ, 20D0354JZ, 20D0610JZ, 20E0428JZ, 20E0429JZ, 20E0522JZ, 20E0829JZ, 20E0830JZ, 20E0831JZ, 20E0832JZ, 20E0833JZ, 20E0834JZ, 20G0042JZ, 20G0043JZ, 20G0044JZ, 20G0045JZ, 20G0046JZ, 20G0047JZ, 20G0048JZ, 20G0050JZ, 20G1257JZ, 20G1258JZ, 20G1259JZ, 20G1260JZ, 20G1261JZ, 20G1262JZ, 20G1263JZ, 20G1264JZ, 20G1265JZ, 20H0339JZ, 20H0873JZ, 20H0874JZ, 20H0878JZ, 20H0879JZ, 20I0452JZ, 20I0729JZ, 20I0874JZ, 20I0875JZ, 20I0876JZ, 20I0877JZ, 20I0878JZ, 20I0879JZ, 20I0880JZ, 20I0881JZ, 20I0882JZ, 20J0894JZ, 20J0895JZ, 20J0896JZ, 20J0897JZ, 20J0898JZ, 20J0900JZ, 20J0901JZ, 20J0902JZ, 20J0903JZ, 20J0904JZ, 20J0905JZ, 20K0595JZ, 20K0596JZ, 20K0597JZ, 20K0598JZ, 20K0599JZ, 20K0600JZ, 20K0601JZ, 20K0602JZ, 20K0603JZ, 20L0518JZ, 20L0519JZ, 20L0520JZ, 20L0521JZ, 20L0522JZ, 21A0806JZ, 21A0807JZ, 21A0808JZ, 21A0809JZ, 21B0732JZ, 21C0168JZ, 21C0169JZ, 21C0170JZ, 21C0171JZ, 21C0172JZ, 21C0173JZ, 21D0815JZ, 21D0816JZ, 21E0080JZ, 21E0082JZ, 21E0085JZ, 21E0087JZ, 21E0088JZ, 21E0089JZ, 21E0090JZ, 21E1131JZ, 21E1132JZ, 21E1133JZ, 21E1366JZ, 21E1367JZ, 21E1368JZ, 21E1369JZ, 21E1370JZ, 21E1371JZ, 21E1372JZ, 21E1373JZ, 21F0867JZ, 21G0312JZ, 21G0390JZ, 21G0391JZ, 21G0392JZ, 21G0393JZ, 21G0394JZ, 21G0395JZ, 21H0055JZ, 21H0056JZ, 21H1089JZ, 21H1090JZ, 21H1091JZ, 21H1092JZ, 21J0123JZ, 21J1179JZ, 21J1180JZ, 21J1181JZ, 21J1182JZ, 21J1183JZ, 22A0207JZ, 22A0208JZ, 22A0209JZ, 22A0210JZ, 22A1120JZ, 22A1244JZ, 22A1245JZ), 20884521551999(D191064978, D191278708, D200314309, D200315927, D200320245, D200320251, D200640190, D201263314, D210205179, D210307270), A8845215519902(20C0235JZ, 20C0395JZ, 20J0906JZ, 20L0685JZ, 21A0234JZ, 21A0824JZ)
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.