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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Oridion Medical 1987 Ltd.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1377-2025

Related Recalls

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.

Feb 17, 2025 Other Medical Devices Nationwide View Details →

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.

Feb 17, 2025 Other Medical Devices Nationwide View Details →

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.

Feb 17, 2025 Other Medical Devices Nationwide View Details →