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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00371-1
Product Name/Description	Transwarmer Infant Transport Mattress Catalogue number: 20421 All batches Order codes: BPOD2-TRANS06 / BPOD2-NEON03 ARTG number: 221364
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	30/04/2015
Responsible Entity	Ferno Australia Pty Ltd
Reason/Issue	CooperSurgical has identified that there may be product with customers that have been in inventory for more than five years. Some users of the TransWarmer Infant Transport Mattress may have removed individual units from the original packaging and have been using the device past the labelled and recommended expiration date. Serious burns have been reported in the past and could occur if the products are not stored under the labelled conditions or used beyond the recommended shelf life. CooperSurgical has received three complaints from the field indicating that the product may activate at higher than labelled temperatures.
Recall Action	Recall
Recall Action Instructions	CooperSurgical is requesting all users to review their inventory and discard or return any product that does not display a product LOT code or expiration date on each individual unit. The brands affected include CooperSurgical and NovaPlus labelled TransWarmer Infant Transport Mattress. The LOT code and expiration date can be located on the top left corner of the individual pouches. All new units will have the lot and expiry date on the individual unit packaging. This action has been closed-out on 17/05/2017.
Contact Information	1800 804 647 - Ferno Australia