The Recall Desk
HighFDA (Devices)·Z-2154-2019·Announced 2019-08-14

SenTec Neonatal Starter Set Recalled for Potential Electrolyte Application Defect

SenTec AG is recalling Neonatal Starter Sets due to a 5% chance of missing or reduced electrolyte application during membrane changes.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that could compromise monitoring accuracy, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

SenTec AG is recalling 10 units of the SenTec Neonatal Starter Set, both with and without Service Gas. The affected lots are 181089, 190051, 190242, 181068, and 190242. These devices are indicated for continuous, non-invasive monitoring of carbon dioxide tension, oxygen tension, oxygen saturation, and pulse rate in adult and pediatric patients, with specific indications for neonatal patients.

The recall is issued because there is an increased chance, approximately 5%, that no electrolyte or a reduced amount of electrolyte is applied to the sensor during the membrane change procedure. This defect may affect the accuracy of the monitoring device.

The products were distributed worldwide, including in the United States (specifically Missouri) and numerous international countries. Users should stop using the affected devices and contact SenTec AG for instructions on replacement or repair.

The recalled product

Product
SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal p
Manufacturer
SenTec AG
Category
Medical Device — Patient Monitoring
Hazard
Affected units
10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Neonatal Starter Set Lots: 181089

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by SenTec AG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · SenTec AG

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