DeVilbiss Disposable Suction Container Filter Recall Due to Fluid Exposure
DeVilbiss Healthcare LLC is recalling specific Disposable Suction Container/Filter units because fluid exposure can occlude the bacterial filter, rendering it unusable.
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. The hazard involves a functional defect (filter occlusion) that renders the device unusable, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
DeVilbiss Healthcare LLC is recalling the DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter). The affected products include the 800 ML DISP Container, Unassembled, the 800 ML DISP Container w/6' patient tubing, and the 800 ML DISP Container w/6' patient tubing, assembled. The recall involves 112,849 units distributed in the USA, Mexico, and Canada. The specific part number is 7305D-634 with model numbers 7305D-632, 7305D-633, and 7305D-633-25.
The recall is being issued because end users exposed the bacterial filter cartridge to fluid. This exposure occluded the filter, rendering it unusable. The product is used to remove fluids from the airway or respiratory support system and infectious materials from wounds.
Consumers and healthcare providers should stop using the affected units. The source text does not specify a particular action for consumers beyond the identification of the defect, but the product is rendered unusable by the described condition.
The recalled product
- Product
- DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction…
- Manufacturer
- DeVilbiss Healthcare LLC
- Affected units
- 112,849
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 (3)
- Part Number 7305D-634 with model numbers 7305D-632
- 7305D-633
- and 7305D-633-25
Distribution
Distribution scope not specified by the agency.
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