Oridion Medical 1987 Ltd.: Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 - Microstream Advance Adult-

Hazard

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.

Details from the source

Reason for recall: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation. Distribution: Worldwide - US Nationwide distribution including in the states of TX, OH, FL, CO, IL, CA, MD, PA, VA, WI, IN, MI, NY, GA, OR, SC, NC, PR, AZ, KY, AR, TN, MO, DE, MA, MS, UT, DC, NE, IA, WV, NJ, KS, LA, WA, HI, MN, AL, ME, RI, OK, MT, ID, CT, NH, AK, NV, SD, WY, ND, NM and the countries of Algeria, Andorra, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, Chi Quantity: 8435772 Lot/code info: Part Number and Revision - REF/UDI-DI(Lot): PT00156254 Rev A - MVAI/20884521761886(C220756034, C221087559, C221192968, C230316355, C230519976, C230837238, C240522589, C240628663, C240729559, D191172616, D201158974, D210312139, D210622030, D210946062, D211154042), 10884521761889(C201200384, C210848192, C210961521, C211092998, C220210315, C220430764, C220538972, C220756034, C220974765, C221087559, C221192968, C230208561, C230314111, C230316355, C230519976, C230523453, C230837238, C231158548, C231158549, C231263415, C240100219, C240522589, C240628663, C240729559, D191172616, D201158974, D201262172, D201262870, D210312139, D210622030, D210946062, D211154042, D220104966, 20G0601JZ, 21A0820JZ, 21A0820JZ, 21A0821JZ, 21A0821JZ, 21A0822JZ, 21C0922JZ, 21G0025JZ, 21G0026JZ, 21G0027JZ, 21G0031JZ, 21G0396JZ, 21G0397JZ, 21G0398JZ, 21H0057JZ, 21H0058JZ, 21H0059JZ, 21H0060JZ, 21H0061JZ, 21H0978JZ, 21H0979JZ, 21H0980JZ, 21H0981JZ, 21H0982JZ, 21I0497JZ, 21I0639JZ, 21I0640JZ, 21J0125JZ, 21J0126JZ, 21J0127JZ, 21J0128JZ, 21J0129JZ, 21J0130JZ, 21J0131JZ, 21J0164JZ, 21J1242JZ, 21J1243JZ, 21J1244JZ, 21J1245JZ, 21J1246JZ, 21J1247JZ, 21J1248JZ, 21J1249JZ, 21J1250JZ, 21J1251JZ, 21J1252JZ, 21K0570JZ, 21K0571JZ, 21K0572JZ, 21K0573JZ, 21K0579JZ, 21K0580JZ, 21K0581JZ, 21K0582JZ, 21K0583JZ, 21K0584JZ, 21K0585JZ, 21K0586JZ, 21K0587JZ, 21K0588JZ, 21K0589JZ, 21L0876JZ, 21L0877JZ, 21L0878JZ, 21L0879JZ, 21L0880JZ, 22A0225JZ, 22A0226JZ, 22A0227JZ, 22A0228JZ, 22A0229JZ, 22A0230JZ, 22A0231JZ, 22A0232JZ, 22A1092JZ,

UPC codes

20884521761886, 10884521761889, 20884521761893, 10884521761896, 10884521761919, 20884521761916, 10884521761926, 10884521762008, 10884521761933, 20884521761909, 10884521761902, 10884521783997, 10884521783980, 20884521762258, 20884521762265, 20884521771762

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.