Agency classClass IIOur severity:High FDA (Devices)·Z-2152-2019·Announced 2019-08-14

SenTec Membrane Changer Recall Due to Electrolyte Application Defect

SenTec AG is recalling 198 Membrane Changer units because a defect may result in insufficient electrolyte application during sensor changes.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 defect that could lead to inaccurate monitoring of vital signs. Per the rubric, this is classified as High because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

SenTec AG is recalling 198 units of the SenTec Membrane Changer (reloadable) [9 pcs]. The product is indicated for continuous, non-invasive monitoring of carbon dioxide tension, oxygen tension, oxygen saturation, and pulse rate in adult and pediatric patients. In neonatal patients, the system is indicated for carbon dioxide and oxygen tension monitoring only.

The recall is due to a defect that creates an increased chance (approximately 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. This issue may affect the accuracy of the monitoring device.

The affected lots are 180763, 180834, 180872, 180874, 180876, 180970, 180993, 181011, 181016, 181031, 181034, 181045, 181072, 181087, 181103, 181141, 190080, 190141, 190165, 190203, 190210, and 190264. The products were distributed worldwide, including in the United States (specifically Missouri) and numerous international locations. Users should check their lot numbers and contact the manufacturer for instructions on how to proceed.

The recalled product

Product: SenTec Membrane Changer (reloadable) [9 pcs] - 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 patients the SDMS is indicated…
Manufacturer: SenTec AG
Category: Medical Device — Monitoring Equipment
Hazard: defective-component
inaccurate-monitoring
Affected units: 198

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 (20)

Lots: 180763
180834
180872
180874
180876
180970
180993
181011
181016
181031
181034
181045
181072
181087
181103
181141
190080
190141
190165
190203

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 →

Same manufacturer · SenTec AG

See all →

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SenTec Digital Monitor Recalled for Missing Isolation Transformer Requirement
FDA (Devices) · 2021-02-24
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SenTec Neonatal Starter Set Recalled for Potential Electrolyte Application Defect
FDA (Devices) · 2019-08-14

Same hazard · defective component