Masimo Corporation Recall 92371
Description: Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
Masimo Corporation Recall 92371 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1986-2023 |
| Event ID | 92371 |
| Event Description | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 |
| Product Type | Devices |
| 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, Guernsey, Hong Kong, Hungary, Iceland, India, Israel, Italy, Japan, Jersey, Jordan, Kenya, Lebanon, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Palestinian Territory, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam. |
| Quantity | 123,745 units |
| Recall Reason | TC-I tip clip sensor may produce readings outside the accuracy specification. |
| Device Classification | 20230628 |
| Device 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 |
| Center Classification Date | 20230621 |
| Recall Initiation Date | 20230421 |
| Recalling Firm | Masimo Corporation |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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