Arjo Flowtron Trio DVT Pump Recalled for Lack of FDA Approval
Arjo, Inc. is recalling 2,859 Flowtron Trio DVT Pumps because they were marketed without proper FDA approval.
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, which typically corresponds to a moderate severity score. The source text does not report any illnesses, injuries, or deaths, and the hazard is regulatory (lack of approval) rather than a specific physical defect causing harm.
Plain-English summary
Arjo, Inc. dba ArjoHuntleigh is recalling 2,859 units of the Flowtron Trio DVT Pump, Model 512003. This prescription intermittent pneumatic compression device is a non-invasive prophylaxis system designed to reduce the incidence of deep vein thrombosis.
The recall was initiated because the device was marketed without proper FDA approval. The affected units were distributed nationwide in the United States, including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Dakota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and Wyoming.
Healthcare facilities and consumers should stop using the affected devices and contact Arjo, Inc. for further instructions.
The recalled product
- Product
- Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis.
- Manufacturer
- Arjo, Inc. dba ArjoHuntleigh
- Category
- Medical Device — DVT Pump
- Affected units
- 2,859
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 (2)
- Model 512003
- all serial numbers
Distribution
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