Sentec Membrane Changer components recalled for manufacturing defect
SenTec AG recalls Membrane Changer components for the Sentec Digital Monitoring System due to a potential manufacturing defect that could affect measurement accuracy.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall without reported illnesses or injuries. The defect presents a potential measurement accuracy issue in a medical monitoring device, consistent with a moderate-risk precautionary recall.
Plain-English summary
SenTec AG is recalling specific lots of three Membrane Changer components used in the Sentec Digital Monitoring System (SDMS). The affected products are Membrane Changer Single-Use (REF MC), Membrane Changer Reloadable (REF MC-R), and Membrane Changer Insert (REF MC-I). Approximately 15,065 packages have been distributed nationwide in the United States.
During manufacturing rework, an additional piece of material may have been left in the devices. This manufacturing defect may result in an impact on the system's measurement performance.
The recalled product
- Product
- Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System…
- Manufacturer
- SenTec AG
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)
- REF MC: 230441
- 230224
- 230209
- 230191
- 230185
- 230167
- 230165
- 230146
- 230125
- 230016
- 225261
- 225226
- 225183
- 225173
- 225149
- 225147
- 225126
- 225122
- 225088
- 225073
Distribution
Distributed nationwide across the United States.
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