Exact FDA event identifier

Event 76062

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: December 16, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Covidien LLC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 40 kg.

Z-1125-2017

Recall number: Z-1125-2017
Initiated: December 16, 2016
Classification: Class II
Status: Terminated
Recalling firm: Covidien LLC
Quantity: 7453 Units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.

Code information

Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H,161970090H, 162040107H, 162110103H, 162320191H, 162390212H

Distribution pattern

Nationwide. Foreign: Belgium Germany France Netherlands