| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01069-1 |
| Product Name/Description |
Medela breastpumps detachable wall plug component of AC Power Adaptor
Supplied with:
Medela Swing, Product #: 030.0040
Medela Swing Maxi, Product #: 040.0011
Medela Swing Premium, Product #: 030.0060
Medela Swing Essentials, Product #: 030.0053
Medela Freestyle, Product #: 042.0014
Stand-alone AC Power Adaptor (for use with Swing Maxi and Freestyle), Product #: 099.0273
Affected AC Power Adaptors were supplied between 2009 and 2016
ARTG Number: 164354 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
The AC Power Adaptors consist of two parts, a detachable wall plug and the power adaptor itself, with cord attached. Medela has received reports of the detachable wall plug component breaking into two parts, thereby potentially exposing a live metallic contact. The exposed contact may create the risk of an electric shock to the user.
There are three types detachable wall plugs, with each breastpump supplied with one of the three types. Not all detachable wall plugs are affected, only those without markings or a dot on the back are affected. The AC Adapter component and the breastpumps themselves are not affected by this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medela is advising users to stop using the AC wall plug if they have an affected detachable wall plug, and to remove the AC wall plug from the wall while the power is switched off. The breastpump may be continued to be used on battery power. Users of affected plugs should contact Medela, who will provide a replacement wall plug.
Medela is advising retailers to isolate or quarantine the affected breastpumps and stand-alone AC adapter, and to stop selling these products immediately. Medela will replace the affected stock. For more details, please see https://www.tga.gov.au/alert/medela-breastpumps-detachable-wall-plug-ac-power-adapter .
This action has been finalised on 2/7/2024. |
| Contact Information |
1800 787 345 - Medela Australia |