Recall Z-2246-2016— DeVilbiss Healthcare LLC

Name: FDA recall Z-2246-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-23

Class II · Terminated

Class II FDA medical device recall by DeVilbiss Healthcare LLC, initiated 2016-05-23, terminated 2017-05-30. It names one FDA 510(k) clearance: K982304. Product: DeVilbiss Model 7305P-D Powered Suction Unit. Reason: A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation..

Recalling firm: DeVilbiss Healthcare LLC
Classification: Class II
Status: Terminated
Initiated: 2016-05-23
Terminated: 2017-05-30
Firm location: Somerset, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K982304 — DEVILBISS SUCTION UNITSunrise Medical Hhg, Inc.·cleared 1998-09-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

DeVilbiss Model 7305P-D Powered Suction Unit

Reason for recall

A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.

Data sourced from openFDA. This site is unofficial and independent of the FDA.