DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. T
FDA device recall Z-0863-2009 · posted 2009-02-10 · Terminated
Recall details
- Recalling firm
- Sunrise Medical
- Reason for recall
- Improper suction: Regulator knob does not turn properly which can affect the suction level.
- Action taken
- 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
- Status
- Terminated
- Product code
- JCX
- Quantity affected
- 78 units
- Distribution
- Worldwide Distribution: USA, Mexico, Guatemala, Colombia, and Costa Rica.
- Date initiated
- 2008-10-27
- Date posted
- 2009-02-10
- Date terminated
- 2012-09-25
- Location
- Somerset, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DEVILBISS SUCTION UNIT (K982304) | Sunrise Medical Hhg, Inc. | 1998-09-25 |