The Recall Desk
HighFDA (Devices)·Z-2246-2016·Announced 2016-07-27

DeVilbiss Model 7305P-D Powered Suction Units Recalled for Premature Failure

DeVilbiss Healthcare LLC is recalling 48 Model 7305P-D Powered Suction Units because a small percentage are experiencing premature failure during operation.

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 involves a medical device with a functional defect (premature failure) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

DeVilbiss Healthcare LLC is recalling 48 units of the DeVilbiss Model 7305P-D Powered Suction Unit. The recall was initiated because a small percentage of these units are experiencing premature failure during operation.

The affected units were distributed in the United States to the states of North Carolina, Ohio, Texas, Missouri, Tennessee, Wisconsin, Kentucky, Florida, Louisiana, Minnesota, Indiana, and South Carolina. The specific serial numbers for the recalled units range from PD465146 to PD465193.

Consumers and healthcare facilities should check their inventory for these specific serial numbers. If a unit is found to be within the affected range, it should be removed from service and returned to DeVilbiss Healthcare LLC for evaluation or replacement.

The recalled product

Product
DeVilbiss Model 7305P-D Powered Suction Unit
Affected units
48

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 (1)

  • Serial numbers: PD465146 - PD465193

Distribution

Distributed in 12 states: