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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01169-1
Product Name/Description	Resus-EZY Air Cushion Mask Catalogue Number: HP-8400, HP-8401, HP-8402, HP-8403, HP-8404, HP-84505 Multiple lot numbers affected Supplied between July 2009 and July 2011 ARTG Number: 143640
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	7/09/2016
Responsible Entity	Schell Medical Corporation Pty Ltd
Reason/Issue	Schell Medical is advising users of an issue regarding product expiry dates for Air Cushion Masks that were purchased between July 2009 and July 2011. These older masks do not have the Expiry date shown on the unit Label. They do have a lot number, which also doubles as the manufacturing date. This date is shown in the ddmmyy format, e.g Lot No. 240511 indicates the mask was manufactured on 24th May 2011. The Life of the mask is 5 years, thus in this example this mask has expired and should be discarded.
Recall Action	Recall
Recall Action Instructions	Schell Medical is advising users to inspect stock and discard any remaining units of the affected lots. Product manufactured since July 2011 includes the expiry date on the label and is unaffected by this issue. This action has been closed-out on 12/05/2017.
Contact Information	1300 361 839 - SMC Customer Service