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Recall Observatory FDA recall evidence

Device 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.

Z-2642-2014

August 03, 2014

Class II

Product summary

Firm
EMG Technology Co., Ltd.
Event
Event 68997
Status
Terminated
Classification
Class II
Quantity
1452
Official record key
device-enforcement:Z-2642-2014

Official wording

Reason: suction canister lids may have occluded ports.

Code information: Product Model No: SUAOI Serial Number ranges: SUI4B01391-SU14B02117. SU14C00556-SU14C01280

Distribution pattern: US Distribution in IL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    suction canister lids may have occluded ports.