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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96309

10 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 17, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Oridion Medical 1987 Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

10 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 10

Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM FilterLine H Set Long Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 007738; MICROSTREAM VitaLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 010807.

Z-1376-2025
Recall number
Z-1376-2025
Initiated
February 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Oridion Medical 1987 Ltd.
Quantity
318292

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Part Number and Revision - REF/UDI-DI(Lot): 006147 Rev N - 006324/20884521551692(C210417257, C210957017, C211102266, C211206691, C220108497, D191171644, D191171646, D191176150, D191278690, D200316307, D200538149, D200639546, D200742524, D200745256, D200950569, D200951852, D201055941, D201261296, D210101027, D210103472, D210310524, D210413725, D210726722, D220211210), 10884521551695(D191171644, D191171646, D191176150, D191278690, D200316307, D200745256, D201261296, D210103472); 007738/20884521216010(D191069375, D191171650, D191176156, D200314292, D200431907, D200537959, D200742194, D200745606, D200950373, D201260700, D210308577, D210728936, D211047680, D211155459); 010807/20884521551920(D200101284, D200426597, D200742219, D200745037, D201260710, D210310546, D210837166), 10884521551923(D200101284, D200745037).

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.

device · product 2 of 10

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
Recall number
Z-1377-2025
Initiated
February 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Oridion Medical 1987 Ltd.
Quantity
5125183

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

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.

device · product 3 of 10

Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), 006324COV; CapnoLine Adult-Pediatric Intubated Filter Line with Microstream Technology Length 7 (2.0 m), XS04620COV; CapnoLine Adult-Pediatric Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), XS04624COV

Z-1378-2025
Recall number
Z-1378-2025
Initiated
February 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Oridion Medical 1987 Ltd.
Quantity
31175

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Part Number and Revision - REF/UDI-DI(Lot): 10129497 Rev B - 006324COV/10884521531574(D200320382, D201260758); XS04620COV/10884521531529(D200322148, D200742380); XS04624COV/10884521531536(D200320376)

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.

device · product 4 of 10

Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989; Omnistream CO2 Sampling Line X25, 010991

Z-1379-2025
Recall number
Z-1379-2025
Initiated
February 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Oridion Medical 1987 Ltd.
Quantity
7076

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Part Number and Revision - REF/UDI-DI(Lot): 01158 Rev E PT00156356 - 010989/20884521762159(C220975945), 20884521552033(D200320259), 10884521762152(C210845590, C220975945, C221193754); 010991/10884521554092(D200638964, D210204584)

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.

device · product 5 of 10

Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 012495;

Z-1380-2025
Recall number
Z-1380-2025
Initiated
February 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Oridion Medical 1987 Ltd.
Quantity
11850

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Part Number and Revision - REF/UDI-DI(Lot): 012808 Rev E - 012495/10884521554122(D210725620, D211155495)

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.

device · product 6 of 10

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, QMVAI; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVAIH

Z-1381-2025
Recall number
Z-1381-2025
Initiated
February 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Oridion Medical 1987 Ltd.
Quantity
3800

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Part Number and Revision - REF/UDI-DI(Lot): PT00134333 Rev A - QMVAI/10884521762329(C201200644); QMVAIH/10884521762336(C210314314)

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.

device · product 7 of 10

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVIIH

Z-1382-2025
Recall number
Z-1382-2025
Initiated
February 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Oridion Medical 1987 Ltd.
Quantity
350

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Part Number and Revision - REF/UDI-DI(Lot): PT00134354 Rev A- QMVIIH/10884521762374(C210314316, C211085494)

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.

device · product 8 of 10

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5ft Short-term use: Procedural/Emergency, MLAI

Z-1383-2025
Recall number
Z-1383-2025
Initiated
February 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Oridion Medical 1987 Ltd.
Quantity
62877

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Part Number and Revision - REF/UDI-DI(Lot): PT00156355 Rev A- MLAI/10884521762145(C210103390, C210103391, C210103392, C220100198, C220101566, C220210015, C220212812, C220430762, C220650161, C220975826, C221087553, C230208559, C230627706, C230733095, C240624686, D201159627, D201262180, D210206012)

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.

device · product 9 of 10

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;

Z-1384-2025
Recall number
Z-1384-2025
Initiated
February 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Oridion Medical 1987 Ltd.
Quantity
8435772

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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, 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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)

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.

device · product 10 of 10

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

Z-1385-2025
Recall number
Z-1385-2025
Initiated
February 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Oridion Medical 1987 Ltd.
Quantity
704423

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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)

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.