Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:16881
Brand Name:Heartsine Pad-Pak/Pedi-Pak Electrode Pack
Model:
Affected:Lot Numbers: A1754, A1795, A1792, A1789, A1802
Software version:
Recalling Organisation:Amtech Medical Ltd
281 Heads Road
Wanganui 4501
Contact Information:0800 268 324
Manufacturer:HeartSine Technologies Ltd
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 type:Recall
Recall action:Product to be returned to supplier
Level of recall:Healthcare Professional
Date Commenced:10/4/2015
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