Recall Z-2319-2013 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
DeVilbiss Healthcare LLC
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 Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It
| Date | Oct 1, 2013 (initiated Mar 7, 2013) |
| Status | Terminated |
| Reason | End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable. |
| Root cause | Use error |
| Action | DeVilbiss Healthcare sent End users a field corrective action letter dated March 7, 2013, to all affected customers to reinforce the proper cleaning method. This letter is to inform you that we have come across cases where end users had exposed the bacterial filter cartridge in the disposable suction container to fluid, thereby occluding the filter and rendering it unusable Specifically what do you have to do when you receive a correction/recall notice? " The US FDA states in its correction/recall regulations that: "Consignees that receive a recall communication should immediately carry out |
| Quantity | 112,849 |
| Distribution | Worldwide Distribution - USA and the countries of Mexico and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982304 | DEVILBISS SUCTION UNIT Sunrise Medical Hhg, Inc., Sep 25, 1998 |