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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00025-1
Product Name/Description	Multiple Manual Pulmonary Resuscitators (Single Use) Catalogue Numbers: HP-9511, HP-9511F, HP-9511FL3, HP-9511PE, HP-9511PF, HP-9833A, HP-9833F, HP-9615ZNST Batch Number: 151013 ARTG Number: 93870
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	22/01/2014
Responsible Entity	Endovations Pty Ltd
Reason/Issue	There have been some reported cases of the Oxygen enrichment bag not inflating automatically when the Oxygen flow is commenced. This is because the bags were folded differently during production.
Recall Action	Recall
Recall Action Instructions	Schell Medical is advising users to quarantine any affected stock. Stock will be replaced with unaffected stock.
Contact Information	1300 361 839 - Schell Medical Customer Service