Masimo Corporation recalls Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895

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)00843997000048 Lot #: 13NBR, 13NBS, 14B96, 14CWW, 14GFV, 14JFW, 14KYQ, 14N03, 15C01, 15EBB, 15HNT, 17DCG, 17DCH,17DCJ, 17DYJ, 17DYK, 17E83, 17E84, 17FAL, 17FAM, 17GER, 17GNT, 17HAV, 17HLA, 17HLB, 17HZD, 17J08,17J09, 17JRE, 17KBQ, 17KBR, 17MDD, 17MDE, 17MPD, 17N06, 17N07, 17NFD, 18A26, 18A27, 18B99, 18BAA, 18CCT, 18CWV, 18CYG, 18DCB, 18EEC, 18ENJ, 18FAG, 18G1V, 18GND, 18GUC, 18H3N, 18HVP, 18J32, 18JPJ, 18JVL, 18K47, 18K52, 18M01, 18M02, 18NAE, 19AAA, 19AHL, 19B2G, 19BFC, 19CAB, 19CAC, 19CUX, 19D83, 19DGK, 19DVR, 19EAJ, 19EAK, 19EVJ, 19F43, 19FUY, 19GCV, 19GSX, 19GZX, 19JEE, 19JVK, 19K42, 19K4V, 19KAM, 19KQB, 19M09, 19M11, 19M2V, 19NDD, 20A4H, 20ABN, 20BBT, 20BKJ, 20BWP, 20C74, 20CRU, 20DAK, 20EQM, 20F49, 20FPD, 20G31, 20G8F, 20HFV, 20HRK, 20J5J, 20JLT, 20K2C, 20KGW, 20KQS, 20MJX, 20MST, 20NGB, 20NGD, 20NUT, 21AGX, 21AXQ, 21BJG, 21BVK, 21CMG, 21DFN, 21EFA, 21EMS, 21EXD, 21EYU, 21F6J, 21FFZ, 21FUH, 21GFE, 21H2M, 21HCT, 21HUC, 21HWH, 21JDQ, 21K4B, 21KGZ, 21MUT, 21MWW, 21NEB, 21NLV, 21NZA, 22ADM, 22BVR, 22CJE, 22CJN, 22CSZ, 22CYA, 22DBL, 22DMJ, 22DSG, 22E72, 22E91, 22EGL, 22EQD, 22EZD, 22F75, 22FHH, 22G2E, 22G68, 22GTT, 22HKY, 22HSC, 22JGD, 22JGE, 22K4N, 22K4P, 22KJM, 22KMJ, 22M7N, 22MCX, 22MZS, 22N6Y, 22N9L, 22NGX, 22NRV, 23AEY, 23AJH, 23BEK, 23BRZ, 23BSS, 23CER, E19DLJ, E20CLS, E20FNS, E20FNT, E20H1G, E20HGW, E21DYY, E21G7M, K16AER, K16DDY, K16GFA, K16JDS, K16KFD, K16KFE, K16NFF,K16NFG,K17AEV, K17AEW, K17B2G, K17BCP, K17BUY, K17CFJ, K17CFK, K17CFM, K17CFN