TGA Ref: RC-2023-RN-00695-1
ARTG: 338960
Affected lots: A3644, A3654, A3655, A3659, A3660, A3664, A3765, A3803, A3840, A3842, A3843, A3844, A3845, A3846, A3847, A3848, A3849, J0748, J0752, J0754, J0755, J0756
The Pad-Pak (item code PAD-PAK-03) is a single use battery and electrode cartridge containing the battery to power the HeartSine samaritan Public Access Defibrillator and two electrode pads to provide the electrical connection for delivery of defibrillation to the patient’s chest.
The affected Pad-Paks may be rendered inoperable due to prematurely depleted battery cells. As a result, the affected Pad-Paks could potentially fail to power on the HeartSine samaritan PAD if needed for use.
If you have an affected Pad-Pak (please refer list of affected LOTs only), contact postmarketssp@stryker.com or call on +61 2 9170 9162 to arrange for a replacement.
Continue monitoring your HeartSine samaritan PAD device/s to ensure the status indicator is flashing green every 5 to 10 seconds.
Contact Stryker immediately if you identify either of the following situations:
Stryker, in consultation with the Therapeutic Goods Administration have initiated this recall.
SSP CA5119