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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Manufacturer
- EMG Technology Co., Ltd.
- Affected units
- 1,452
Distribution
Distributed in 1 state:
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