Recall Z-2642-2014

EMG Technology Co., Ltd. · initiated August 3, 2014

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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.

Codes / lots: Product Model No: SUAOI Serial Number ranges: SUI4B01391-SU14B02117. SU14C00556-SU14C01280

Reason for recall

suction canister lids may have occluded ports.

FDA-determined cause: Nonconforming Material/Component

Action taken

A recall letter, dated August 6, 2014, was sent via email which identified the product, problem, and actions to be taken.

Details

Recall number
Z-2642-2014
Initiated
August 3, 2014
Posted by FDA
September 13, 2014
Terminated
August 25, 2015
Product code
JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
Quantity
1452
Distribution
US Distribution in IL.
Recalling firm
EMG Technology Co., Ltd., Taichung

Official FDA recall record