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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00364-1
Product Name/Description	Devon Light Glove Item Number and Item Description 571711 NS-3600-B LITE GLOVE 31140208 3611 LITE GLOVE 31140216 3613 LITEGLOVE CS192 31140257 3612 THEATRE LITE GLOVE Lot numbers beginning with 508xxxx or lower Manufactured: March 2012 through March 2015 ARTG number: 186761
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	24/04/2015
Responsible Entity	Covidien Pty Ltd
Reason/Issue	Covidien received reports that the light glove may contain splits or holes or be torn. Should the user be unaware that the Light Glove is torn or split, a mode of transfer of microorganisms from the light handle into the patient wound is possible in the event the clinician touches the handle and then the sterile field. No adverse events have been reported.
Recall Action	Recall
Recall Action Instructions	Covidien is requesting the customers to immediately quarantine and discontinue use of the affected devices. Replacement product is not available at this time and Covidien will be issuing credit for the returned, unused and unexpired device(s). This action has been closed-out on 08/08/2016.
Contact Information	02 9429 3114 - Covidien