DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. The device may include a microbial filter.
FDA Recall Z-0863-2009 · Posted 2009-02-10
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Recalling FirmSunrise Medical
Recall StatusTerminated
Product CodeJCX
Date Initiated2008-10-27
Date Terminated2012-09-25
Product Quantity78 units
Reason for Recall
Improper suction: Regulator knob does not turn properly which can affect the suction level.
Firm Action
DeVilbiss notified dealers and users (through the dealers) to recall the units, by a telephone call October 27, 2008 followed by an Urgent Medical Device Recall mailing November 3, 2008. The letter advised customers what models are affected and how to contact the firm of dealer to have the affected unit replaced. Corrective and preventative action on current manufacturing has been implemented.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution: USA, Mexico, Guatemala, Colombia, and Costa Rica.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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