Reported Jun 28, 2023 · Ongoing
Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
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 RD Set TC-I SpO2 Adult Reusable Ear Sensor
- REF4053
- Lot codes and dates
- UDI-DI
103 of 103 codes
(01)00843997009904 Lot #: E16JZJE16N2C17A3A17AKM17AKN17CPV17DBE17E8717E8817FAQ17GEV17J1317KBP17KWZ17MDH18AEG18DCE18E0418GNZ18HKS18J3518JPH18JWM18K4918KST18M0319BFG19CBA19D8719DZS19EAN19F4719GCW19HDJ19HTV19K3N19KAP19KPZ19M2U19MKM19NRL20ABM20C7620C9420DAL20FUR20G2S20HFU20KMY20KUE20MNW20NGC21ASU21CBY21CTU21E0821E0921EMQ21EMR21EYS
- UDI-DI
- Amount recalled
- 138,926 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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