Masimo Corporation: Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503

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: 123,745 units Lot/code info: UDI-DI: (01)00843997003230 Lot #: 13HBT, 15DAV, 17FAN, 17HAX, 17J12, 17MDF, 17N09, 18A28, 18AVB, 18CUV, 18FQZ, 18J33, 18K48,18KSS, 18MBC, 19ALF, 19CAY, 19D84, 19HMB, 19N1C, 20CRT, 20FMM, 20KWK, 21CRG, 21EMP, 21FFY,21FWV, 21G2K, 21GTL, 21HWG, 21KGD, 21MEF, 22AVS, 22BSC, 22DGZ, 22DUG, 22ESP, 22GDZ, 22J4J,22K64, 22NYC, 23AAE, E21DXT, K16HCA, K16JFC, K17BCR

UPC codes

00843997003230

Source

Official record: FDA (Device enforcement) ↗

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