Recall Z-2642-2014 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
EMG Technology Co., Ltd.
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.
| Date | Sep 13, 2014 (initiated Aug 3, 2014) |
| Status | Terminated |
| Reason | suction canister lids may have occluded ports. |
| Root cause | Nonconforming Material/Component |
| Action | A recall letter, dated August 6, 2014, was sent via email which identified the product, problem, and actions to be taken. |
| Quantity | 1452 |
| Distribution | US Distribution in IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042349 | EMG MODEL SUA01 SUCTION UNIT Emg Technology Co., Ltd., Dec 16, 2004 |