SenTec Standard Starter Set Recalled for Potential Electrolyte Deficiency
SenTec AG is recalling Standard Starter Sets due to a risk of missing or reduced electrolyte application during the membrane change procedure.
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 is classified as FDA Class II, and the hazard involves a risk of harm (inaccurate monitoring) where specific injury or illness has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
SenTec AG is recalling the SenTec Standard Starter Set, with and without Service Gas, containing two changers each. The recall involves 22 units distributed worldwide, including in the United States (specifically Missouri) and numerous international locations.
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 product is 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.
Consumers and healthcare facilities should stop using the affected units and contact SenTec AG for instructions on replacement or return. The affected lot numbers for the Standard Starter Set are 180932, 180959, 181019, 181082, 190005, 190041, 190093, 190221, and 190282. The lot numbers for the Standard Starter Set without Service Gas are 180972 and 190078.
The recalled product
- Product
- SenTec Standard Starter Set with and without Service Gas (2 changers 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
- Affected units
- 22
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 (9)
- Standard Starter Set Lots: 180932
- 180959
- 181019
- 181082
- 190005
- 190041
- 190093
- 190221
- and 190282. Standard Starter Set (without Service Gas) Lots:180972 and 190078
Distribution
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.
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