CLASS II Device recall · Reported 5 Jul 2017 · FDA Enforcement Report

MasimoSET Lnop Dcip pediatric/slender digit SpO2 reusable recalled

Merge Healthcare is recalling MasimoSET Lnop Dcip pediatric/slender digit SpO2 reusable sensor, finger clip pediatric, distributed nationwide in the US. The recall was initiated on 4 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesThe following lot numbers are affected and are not specific to each cable/sensor type: 09AP8, 10AEU, 10KBN, 09CF9, 10BMN, 10MDN, 09CNS, 10FEN, 10MDN, 09KG6, 10F95, 10DUT, 09KG6, 10F95, 10DDK, 09NMN, 10BMN, 10DUT, 10A81, 10GJB, 10KBS, 09NMN, 10BMN, 10DUT, 10AEU, 10GJB, 10KBS, 10AEU, 10KBN, 10KBS, 11AGS, 11KAJ, 11CFT, 10KFP, 11N61, 11DAY, 11AGS, 11NG2, 11CFT, 11AGS, 12CNX, 11DDK, 12FMH, 12C68, 11FBS, 12GEB, 12C68, 11JBK, 12GEB, and 12FMH.

Quantity recalled4 sensors

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2642-2017
FDA event ID: 76974
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 4 Apr 2016
FDA classified: 29 Jun 2017
Reported: 5 Jul 2017
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Temperature Abuse
Device type: Heart & Vascular Devices

Timeline

4 Apr 2016	Recall initiated by company
29 Jun 2017	Classified by FDA	+451 days
5 Jul 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.

Where it was distributed

Distribution was nationwide. There was also government and military distribution. There was no foreign distribution.

Nationwide

Questions about this recall

Why was it recalled?

Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.

Which lots are affected?

The following lot numbers are affected and are not specific to each cable/sensor type: 09AP8, 10AEU, 10KBN, 09CF9, 10BMN, 10MDN, 09CNS, 10FEN, 10MDN, 09KG6, 10F95, 10DUT, 09KG6, 10F95, 10DDK, 09NMN, 10BMN, 10DUT, 10A81, 10GJB, 10KBS, 09NMN, 10BMN, 10DUT, 10AEU, 10GJB, 10KBS, 10AEU, 10KBN, 10KBS, 11AGS, 11KAJ, 11CFT, 10KFP, 11N61, 11DAY, 11AGS, 11NG2, 11CFT, 11AGS, 12CNX, 11DDK, 12FMH, 12C68, 11FBS, 12GEB, 12C68, 11JBK, 12GEB, and 12FMH.

Where was it sold?

Distribution was nationwide. There was also government and military distribution. There was no foreign distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 76974

This product is part of a recall event; the main page for the event is Masimo SPO2 Sensor, ear clip-adult (Merge recalled by Merge Healthcare.

Reported	Class	Recall	Company	Reason	Where
5 Jul 2017	CLASS II	Masimo SPO2 Sensor, ear clip-adult (Merge recalled by Merge Healthcare	Merge Healthcare	Temperature Abuse	Nationwide
5 Jul 2017	CLASS II	SpO2 connecting cable for Masimo LNCS sensor (Merge recalled	Merge Healthcare	Temperature Abuse	Nationwide
5 Jul 2017	CLASS II	MasimoSET LNOP DCI adult SpO2 reusable sensor recalled	Merge Healthcare	Temperature Abuse	Nationwide

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