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Terminated

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.

FDA Recall Z-2642-2014 · Posted 2014-09-13

Recalling FirmEMG Technology Co., Ltd.
Recall StatusTerminated
Product CodeJCX
Date Initiated2014-08-03
Date Terminated2015-08-25
Product Quantity1452

Reason for Recall

suction canister lids may have occluded ports.

Firm Action

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

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Distribution in IL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042349EMG MODEL SUA01 SUCTION UNITEmg Technology Co., Ltd. · 2004-12-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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