Z-1722-2025Class II

Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm...

Name: Z-1722-2025 Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm...
Creator: Philips North America Llc
Published: 2025-04-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2025-04-07 / Open, Classified

FDA source

Philips North America Llc began a recall of 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... on 2025-04-07. FDA classified it as Class II and gives the reason as "Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1722-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-07
Posted: 2025-05-05
Recalling firm: Philips North America LLC
Product: 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 Set Infant/Neonatal , FilterLine Set Long Adult/Pediatric , FilterLine H Set Long Adult/Pediatric , FilterLine H Set Long Infant/Neonatal , Trade Compliant: FilterLine H, Adult/Ped , Trade Compliant: FilterLine H, Infant/Neo , FilterLine Set Adult/Pedi , FilterLine H Set Adult/Pedi and FilterLine H Set Infant/Neonatal. Carbon dioxide gas analyzer.
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Reason for recall: Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
FDA 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 [email protected] or by fax to 877-499-7723. Distributors are asked to forward the provided recall notification to customers no later than 5 days after notification of this recall event and to conduct a good faith effort to get a completed Response Form from each of their customers by conducting a minimum of three follow ups utilizing multiple contact methods. Consignees or Distributors with any questions are to contact 1-800-722-9377. Philips plans to issue an IFU addendum to address the recall.
Quantity in commerce: 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, KG, KR, KW, LB, LK, LT, LU, LV, LY, MA, MC, MM, MO, MQ, MT, MU, MV, MX, MY, MZ, NC, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PG, PH, PK, PL, PM, PR, PS, PT, PY, QA, RE, RO, RS, RU, RW, SA, SE, SG, SI, SK, SN, SY, TH, TN, TR, TT, TW, TZ, UA, UY, VA, VN, YT, ZA.
Product codes and lots: Model No. 989803204511, 989803204321, 989803204301, 989803204331, 989803204521, 989803204531, 989803204311, 989803204341, 989803159571, 989803159581, 989803160241, 989803160251, 989803160261, 989803182921, 989803182931, 989803105531, 989803105541, 989803105561; UDI: N/A; System Codes 989803105531, 989803105541, 989803105561, 989803159581, 989803160241, 989803160251, 989803160261, 989803182921, 989803182931, 989803204301, 989803204311, 989803204321, 989803204331, 989803204341, 989803204511, 989803204521, 989803204531, 989803159571, 989803159581, 989803160241, 989803160251, 989803160261, 989803182921, 989803182931, 989803204301, 989803204311, 989803204321, 989803204331, 989803204341, 989803204511, 989803204521, 989803204531, M1920A, M1921A, M1923A.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1722-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1722-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-05

Product code CCK

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)