Reported Jun 28, 2023 · Ongoing
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
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
- REF1895
- Lot codes and dates
- UDI-DI
205 of 205 codes
(01)00843997000048 Lot #: 13NBR13NBS14B9614CWW14GFV14JFW14KYQ14N0315C0115EBB15HNT17DCG17DCH17DCJ17DYJ17DYK17E8317E8417FAL17FAM17GER17GNT17HAV17HLA17HLB17HZD17J0817J0917JRE17KBQ17KBR17MDD17MDE17MPD17N0617N0717NFD18A2618A2718B9918BAA18CCT18CWV18CYG18DCB18EEC18ENJ18FAG18G1V18GND18GUC18H3N18HVP18J3218JPJ18JVL18K4718K5218M0118M02
- UDI-DI
- Amount recalled
- 443,799 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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