Recall Z-1722-2025 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Philips North America Llc
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Line LTerm Lng , Adt/Pedi Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line High Humidity , Neo/Inf Intub CO2 Line LTerm Lng , VitaLine H Set Adult/Pediatric , VitaLine H S
| Date | May 5, 2025 (initiated Apr 7, 2025) |
| Status | Open, Classified |
| Reason | Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible. |
| Root cause | Unknown/Undetermined by firm |
| Action | Consignees and Distributors were mailed an URGENT Medical Device Correction notice dated 4/7/25. Consignees were instructed to continue using the devices per the IFU and to ensure during setup that the airway adapter can easily be attached and detached from the breathing circuit/tubing before proceeding. The provided recall notification should be forwarded to those in the organization who use the device or where devices may have been transferred. Consignees are asked to utilize the provided QR code to complete a Response Form digitally; consignees can also email a hard copy Response Form to |
| Quantity | 486,631 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of AE, AL, AO, AR, AT, AU, AW, BD, BE, BG, BH, BO, BR, BW, BY, CA, CD, CH, CI, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, ET, FI, FJ, FO, FR, GA, GB, GF, GH, GI, GP, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KE, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113441 | PHYSIOLOGICAL MONITOR, PATIENT MONITOR Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Mar 22, 2012 |
| K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line Oridion Medical 1987 , Ltd., Feb 8, 2019 |
| K980324 | MICROSTREAM FILLERLINE OR/EMS Oridion Medical , Ltd., Apr 16, 1998 |
| K980327 | MICROSTREAM FILTERLINE ICU Oridion Medical , Ltd., Apr 16, 1998 |
| K993383 | HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B Hewlett-Packard GmbH, Feb 3, 2000 |