Reported Jun 28, 2023 · Ongoing
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
Masimo Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Masimo Corporation · 52 Discovery · Irvine, CA · 92618-3105
Is this the product you have?
- Masimo LNCS TC-I SpO2, Reusable Ear Sensor
- REF2503
- Lot codes and dates
- UDI-DI
(01)00843997003230 Lot #: 13HBT15DAV17FAN17HAX17J1217MDF17N0918A2818AVB18CUV18FQZ18J3318K4818KSS18MBC19ALF19CAY19D8419HMB19N1C20CRT20FMM20KWK21CRG21EMP21FFY21FWV21G2K21GTL21HWG21KGD21MEF22AVS22BSC22DGZ22DUG22ESP22GDZ22J4J22K6422NYC23AAEE21DXTK16HCAK16JFCK17BCR
- UDI-DI
- Amount recalled
- 123,745 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
TC-I tip clip sensor may produce readings outside the accuracy specification.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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