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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01389-1
Product Name/Description	LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED with a pink connector Electrode Catalogue Number: 111401-000016 MIN: 3202380-006 Lot Numbers: 713609, 717912, 713904, 718033, 715008 and 719323 Electrode Start Kits Catalogue Number: 11101-000017 MIN: 3202784-009 Lot Numbers: 45932237, 46042286, 45979590, 46050960, 45979954, 46052545, 46007867, 46061770, 46023185, 46063054, 46023823 and 46078012 ARTG Number: 232970
Recall Action Level	Retail
Recall Action Classification	Class I
Recall Action Commencement Date	8/11/2017
Responsible Entity	Physio-Control Australia Pty Ltd
Reason/Issue	Physio-Control is notifying customers of an issue with the artwork on the defibrillation electrodes, as manufactured by Cardinal Health, does not meet Physio-Control’s specifications, and shows incorrect electrode placement for an infant. There is no issue with the performance or function of the defibrillation electrodes; this is limited to incorrect artwork on the defibrillation electrodes within the packaging. If the user incorrectly places the defibrillation electrodes it may result in ineffective energy delivery to the patient. This may result in failure to defibrillate and serious injury or death. There have been no reports of injuries associated with this issue.
Recall Action	Recall
Recall Action Instructions	Users are advised to inspect the "Electrode pouch and box labelling" and the "Electrode Starter Kit box labelling" to determine if the electrodes are affected. Users are advised to place of copy of the correct electrode packaging and labelling with each affected AED, until the electrodes have been replaced by Physio- Control.
Contact Information	1800 987 982 (option 2, then option 2) - Physio-Control Customer Service