Class 2 Device Recall VacAssist Suction Units

• Date Initiated by Firm: August 03, 2014
• Date Posted: September 13, 2014
• Recall Status: Terminated 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
• FEI Number: 3003803075
• 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: 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