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

Hazard

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

Details from the source

Reason for recall: TC-I tip clip sensor may produce readings outside the accuracy specification. Distribution: US: 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 OUS: Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Gibraltar, Guerns Quantity: 86 units Lot/code info: UDI-DI: (01)00843997000239 Lot #: K16ANC, K16MWR, K17AEU, 17EGQ

UPC codes

00843997000239

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.