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.
Reason for recall: 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. Distribution: 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, Quantity: 24,249 units Lot/code info: Model Number (UDI-DI Number): DE2100X13B (606959054103); DS2100X11B (606959051997); EE2100X15B (606959055698); ES2100X15B (606959054097); EU2100X15B (606959055674); EU2100X19 (606959055681); FP2100X10 (606959062085); FR2100X14B (606959055643); FX2100X15B (606959061019); IA2100X15B (606959055636); IN2100X15B (606959054059); IN2100X19 (606959055575); IT2100X21B (606959055438); JP2100X16B (606959055582); LA2100X15B (606959055599); ND2100X15B (606959055650). All Serial Numbers.
606959054103, 606959051997, 606959055698, 606959054097, 606959055674, 606959055681, 606959062085, 606959055643, 606959061019, 606959055636, 606959054059, 606959055575, 606959055438, 606959055582, 606959055599, 606959055650
Official record: FDA (Device enforcement) ↗
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