| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00655-1 |
| Product Name/Description |
HeartSineTechnologies Pad-Pak/ Pedi-Pak (contains non-rechargeable battery and defibrillation electrodes for use with the HeartSine Samaritan PAD 350P and 500P Defibrillators)
Lot Numbers: A1754, A1795, A1792, A1789, A1802
ARTG Numbers: 161839 (Adult Pad-Pak) and 161841 (Paediatric Pedi-Pak) |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
18/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
During testing at HeartSine Technologies Ltd, an issue has been detected with the seal on the foil pouch which contains the electrodes within the Pad-Pak and Pedi-Pak. On a small number, the final seal on the defibrillation electrode pouch was found to be difficult to open. The investigation identified that the supplier of the electrodes to HeartSine Technologies Ltd had made a change to the manufacturing process which meant that an excessive amount of hot melt glue was applied to the final seal of the pouches. |
| Recall Action |
Recall |
| Recall Action Instructions |
Aero Healthcare is advising that all the affected units are within the control of the distributors. The distributors are advised that the affected units should be placed in quarantine to await collection by Aero Healthcare. |
| Contact Information |
02 6776 7200 - Aero Healthcare |