Z-1377-2025Class II

Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets &...

Name: Z-1377-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets &...
Creator: Oridion Medical 1987 Ltd.
Published: 2025-02-17
License: https://open.fda.gov/license/

Oridion Medical 1987 Ltd. / initiated 2025-02-17 / Open, Classified / root cause: labeling and UDI

FDA source

Oridion Medical 1987 Ltd. began a recall of Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM... on 2025-02-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1377-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-17
Posted: 2025-03-17
Recalling firm: Oridion Medical 1987 Ltd.
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.
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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 [email protected] 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.
Quantity in commerce: 5125183
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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1377-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1376-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-17
Z-1377-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-17
Z-1378-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-17
Z-1379-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-17
Z-1380-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-17
Z-1381-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-17
Z-1382-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-17
Z-1383-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-17
Z-1384-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-17
Z-1385-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-17

Product code CCK

K181467Class IIMicrostream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter LineOridion Medical 1987 , Ltd. / cleared 2019-02-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)