The Recall Desk
SevereFDA (Devices)·Z-2642-2014·Announced 2014-09-24

EMG Technology Recalls Vac-Assist Suction Units Due to Occluded Ports

EMG Technology is recalling 1,452 Vac-Assist Suction Units because the canister lids may have occluded ports, potentially preventing proper fluid removal.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of failure to remove critical fluids from a patient's airway.

Plain-English summary

EMG Technology Co., Ltd. is recalling 1,452 units of the Vac-Assist Suction Unit (Model SUA01) with an 800 cc canister. The recall is due to a defect where the suction canister lids may have occluded ports. This issue could prevent the device from properly removing fluids from a patient's airway or respiratory support unit.

The affected devices are intended for professional use in both adult and pediatric populations. The specific serial number ranges for the recalled units are SU14B01391-SU14B02117 and SU14C00556-SU14C01280. The products were distributed in Illinois.

Healthcare facilities and users should stop using the affected units immediately. They should contact EMG Technology Co., Ltd. for instructions on how to return the devices for repair or replacement.

The recalled product

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.
Affected units
1,452

Distribution

Distributed in 1 state: