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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00281-1
Product Name/Description	STERRAD 100S Cassettes Product Code: 10113 Lot Numbers; 13I038, 13I046, 13I071, 13I072, 13I077, 13I078, 13I083, 13I084, 13I090, 13I121, 13K003, 13K074, 13K105, 13L021, 14A030 & 14A031 ARTG Number: 123602
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	4/03/2014
Responsible Entity	Johnson & Johnson Medical Pty Ltd
Reason/Issue	The manufacturer, ASP has identified that the misaligned barcodes may cause the cassette to be slightly out of position. The barcode on the STERRAD 100S Cassette is used to register the position of the cassette in the sterilizer. An out of position cassette may cause the first cycle on that cassette to cancel, or in extreme cases may cause the injection needles used to remove hydrogen peroxide from the STERRAD 100S Cassette to be damaged. The position of the barcode on the affected lots is variable and the probability of resulting damage to the injection needles is low.
Recall Action	Recall
Recall Action Instructions	Johnson & Johnson Medical is advising users to continue to use current stock until a replacement product has been provided. Affected stock can be returned to Johnson & Johnson Medical once unaffected stock has been received. This action has been closed-out on 12/02/2016.
Contact Information	1800 883 771 - ASP Field Service Engineer