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U.S. Department of Health and Human Services

Class 2 Device Recall VacAssist Suction Units

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  Class 2 Device Recall VacAssist Suction Units see related information
Date Initiated by Firm August 03, 2014
Date Posted September 13, 2014
Recall Status1 Terminated 3 on August 25, 2015
Recall Number Z-2642-2014
Recall Event ID 68997
510(K)Number K042349  
Product Classification Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
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.
Code Information Product Model No: SUAOI Serial Number ranges: SUI4B01391-SU14B02117. SU14C00556-SU14C01280 
Recalling Firm/
Manufacturer		 EMG Technology Co., Ltd.
No. 58, 35 Road
Taichung Industrial Park
Taichung Taiwan
Manufacturer Reason
for Recall		 suction canister lids may have occluded ports.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action A recall letter, dated August 6, 2014, was sent via email which identified the product, problem, and actions to be taken.
Quantity in Commerce 1452
Distribution US Distribution in IL.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JCX and Original Applicant = EMG TECHNOLOGY CO., LTD.
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