Z-2642-2014 Class II Terminated
FDA device recall Z-2642-2014 was initiated by EMG Technology Co., Ltd. on August 3, 2014 and is designated Class II. Reason for recall: suction canister lids may have occluded ports. The recall status is terminated (terminated August 25, 2015). Affected quantity: 1452.
Recall Details
- Product Type
- Devices
- Report Date
- September 24, 2014
- Initiation Date
- August 3, 2014
- Termination Date
- August 25, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1452
Product Description
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.
Reason for Recall
suction canister lids may have occluded ports.
Distribution Pattern
US Distribution in IL.
Code Information
Product Model No: SUAOI Serial Number ranges: SUI4B01391-SU14B02117. SU14C00556-SU14C01280