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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01188-1
Product Name/Description	Fisher & Paykel Healthcare Infant Warmer Pivot Securing Nut Infant Warmers Model Numbers: IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX & IW980XXX Serial Numbers: 071116ZZZZZZ to 090810ZZZZZZ Spare Parts: Model Numbers: 043041129, 043041130, 043041131, 043042359, 648040142 Lot Numbers: 071116 - 090810 (all spare parts) ARTG number: 100660
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	6/11/2014
Responsible Entity	Fisher & Paykel Healthcare Pty Ltd
Reason/Issue	Fisher & Paykel Healthcare is issuing this recall notice because it has had two confirmed reports of breakage of the nut that secures the heater head in place. Breakage of the nut can cause the heater head to become partially detached and swing towards the bassinet. The heater head did not contact the patient in either case, however there is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.
Recall Action	Recall for Product Correction
Recall Action Instructions	Fisher & Paykel Healthcare is providing replacement nut to support the heater head and prevent falling. This action has been closed-out on 04/09/2018.
Contact Information	03 9879 5022 - Fisher & Paykel Healthcare