Z-2642-2014Class II

Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for...

Name: Z-2642-2014 Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for...
Creator: EMG Technology Co., Ltd.
Published: 2014-08-03
License: https://open.fda.gov/license/

EMG Technology Co., Ltd. / initiated 2014-08-03 / Terminated / root cause: manufacturing process

FDA source

EMG Technology Co., Ltd. began a recall of 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... on 2014-08-03. FDA classified it as Class II and gives the reason as "suction canister lids may have occluded ports". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2642-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-03
Posted: 2014-09-13
Terminated: 2015-08-25
Recalling firm: EMG Technology Co., Ltd.
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.
Product code: JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Reason for recall: suction canister lids may have occluded ports.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Product Model No: SUAOI Serial Number ranges: SUI4B01391-SU14B02117. SU14C00556-SU14C01280

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2642-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2642-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-12

Product code JCX

K042349Class IIEMG Model Sua01 Suction UnitEmg Technology Co., Ltd. / cleared 2004-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)