Infinium Medical Recalls CLEO and Tranquility VS Patient Monitors
Infinium Medical is recalling 95 CLEO and Tranquility VS patient monitors because their FDA clearance did not include the temperature monitor accessory option.
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: The recall is classified as FDA Class II, but the source text describes a regulatory labeling/indication issue without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Infinium Medical, Inc. is recalling 95 CLEO and Tranquility VS Patient Monitors. The recall was initiated because the devices' 510(k) indications for use in the United States did not include the temperature monitor accessory option.
The affected devices were distributed nationwide to California, Georgia, Louisiana, Florida, Maryland, Minnesota, Puerto Rico, South Carolina, Virginia, and Wisconsin. Specific serial numbers for the recalled units are listed in the official recall documentation.
Consumers and healthcare facilities should stop using the affected devices and contact Infinium Medical for instructions on how to proceed.
The recalled product
- Product
- CLEO Patient Monitor /Tranquility VS Patient Monitor
- Manufacturer
- Infinium Medical, Inc
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 95
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)
- Serial Numbers - A18094501812
- A18014501391
- A18014600053
- A18014600070
- A18014600080
- A18014501432
- A18014501438
- A17074501202
- A17084501263
- A17024500996
- A16054500521
- 45000082
- 45000084
- 45000085
- 45000057
- 45000058
- A1 8094501659
- A17044501052
- A17024500972
- A160104500653
Distribution
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