| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00281-1 |
| Product Name/Description |
Meducore Easy Automatic External Defibrillator (AED) - Battery Pack
Battery Pack Model Number: WM 40155
Serial Numbers: 15120, 15122, 15127, 15121, 15119, 15126, 15118, 15117, 15116 & 15128
ARTG Number: 214662 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been identified that in rare cases, the Meducore Easy Battery Pack may fail. In the event of failure, it would no longer be possible to administer a shock to the patient, which could lead to unsuccessful resuscitation. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
USL Medical will be providing users with a replacement battery. Once the replacement battery is received, users are to immediately remove and discard the affected battery and insert the new battery into the device. Whilst waiting on the replacement battery, USL Medical recommends close monitoring of the status indicators on the front of the Meducore Easy AED to ensure battery and device readiness.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 339 300 - USL Medical |