medical Class II Updated 2023-06-28

Masimo Corporation recalls Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794

Recalled Product

Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794


Hazard / Issue

TC-I tip clip sensor may produce readings outside the accuracy specification.

Issued by

FDA

Affected States: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY
Lot/Code Info: UDI-DI: (01)00843997000239 Lot #: K16ANC, K16MWR, K17AEU, 17EGQ
View official government recall

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