Recall Z-2642-2014— EMG Technology Co., Ltd.

Name: FDA recall Z-2642-2014
Creator: U.S. Food and Drug Administration
Published: 2014-08-03

Class II · Terminated

Class II FDA medical device recall by EMG Technology Co., Ltd., initiated 2014-08-03, terminated 2015-08-25. It names one FDA 510(k) clearance: K042349. Product: Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.. Reason: suction canister lids may have occluded ports..

Recalling firm: EMG Technology Co., Ltd.
Classification: Class II
Status: Terminated
Initiated: 2014-08-03
Terminated: 2015-08-25
Firm location: Taichung, N/A, Taiwan

510(k) clearances named in this recall

1 on FDA's record

K042349 — EMG MODEL SUA01 SUCTION UNITEmg Technology Co., Ltd.·cleared 2004-12-16

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

Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.

Reason for recall

suction canister lids may have occluded ports.

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