—#213390

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.

FDA product code: CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K113441, K181467, K980324, K980327, K993383
Affected lot / code info: 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.

Why it was recalled

Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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 Recall.Response@fda.hhs.gov 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.

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-04-07
Posted by FDA: 2025-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213390. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.