Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B, EE2200X15B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.

Reason: Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

Code information: Model Number (UDI-DI Number): DS2200X11B (606959052017); IN2200X15B (606959056497); BL2200X15B (606959058668); BR2200X18B (606959058583); CA2200X12B (606959052321); DE2200X13B (606959058651); GB2200X15B (606959058675); ND2200X15B (606959058620); ES2200X15B (606959058644); FR2200X14B (606959058613); FX2200X15B (606959061033); EU2200X15B (606959058682); IA2200X15B (606959058606); IT2200X21B (606959058637); KR2200X15B (606959058590); TR2200X15B (606959058798); EE2200X15B (606959058705). All Serial Numbers.

Distribution pattern: Worldwide distribution - US Nationwide and the countries of AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, LY, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, TZ, UA, UY, VN, YT, ZA, ZW.