| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00174-1 |
| Product Name/Description |
Cook Aspiration Unit
Part Numbers: K-MAR-5200, K-MAR-5200-US
Global Product Numbers: G49275, G51067
ARTG Number:156032
(William A Cook Australia - Suction unit, electric powered) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
A recent design review of the K-MAR-5200 Aspiration Unit, identified that the internal mains wiring does not fully comply with the requirements of the medical electrical equipment standard IEC60601-1 Edition 3.0. IEC60601-1. This standard states that conductors and connectors of medical electrical equipment shall be secured or insulated so that accidental detachment shall not result in a hazardous situation. The K-MAR-5200 mains wiring is secured, but the mechanism is not considered suitable under IEC60601-1.
To date, no harm has been reported as a result of this issue |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Cook Medical is advising that they will be replacing the mains wiring for affected each unit. An authorised service agent will contact users to arrange for impacted devices to be corrected.
In the interim, Cook Medical recommends that a residual current device (RCD), also known as a ground fault circuit interrupter (GFCI), ground fault interrupter (GFI), or an appliance leakage current interrupter (ALCI) is fitted to the mains electricity supply to mitigate the risk of a hazardous situation.
This action has been closed out on 29/03/2021 |
| Contact Information |
1800 777 222 - Customer Service Support |