Recall Z-0863-2009 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Sunrise Medical
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.
| Date | Feb 10, 2009 (initiated Oct 27, 2008) |
| Status | Terminated |
| Reason | Improper suction: Regulator knob does not turn properly which can affect the suction level. |
| Root cause | Device Design |
| 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. |
| Quantity | 78 units |
| Distribution | Worldwide Distribution: USA, Mexico, Guatemala, Colombia, and Costa Rica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982304 | DEVILBISS SUCTION UNIT Sunrise Medical Hhg, Inc., Sep 25, 1998 |