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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00293-1
Product Name/Description	ConMed Hyfrecator 2000 Electrosurgical Unit and Accessory Packages containing Handpiece Sheaths ConMed Hyfrecator 2000 Electrosurgical Unit Reference Number: 7-900-230 Multiple Serial Numbers Accessory Package containing Handpiece Sheaths Reference Number: 7-796-19 Lot Numbers: 201511234, 201512074, 201512094, 201601064, 201603284 ARTG Number: 130647
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	28/02/2017
Responsible Entity	ConMed Linvatec Australia Pty Ltd
Reason/Issue	ConMed has identified that Accessory Packages contained within the Hyfrecator 2000 carton were packaged in error by the manufacturer, with non-sterile Handpiece Sheaths (Ref. 7-796-19) packaged in pouches that were labelled “sterile”. This could cause an end user to use a non-sterile sheath as if it were sterile. ConMed has not received any reports that this mislabelling has resulted in injury or illness. Only Sheaths supplied in the original Accessory Package of affected Hyfrecator cartons are mis-labelled.
Recall Action	Recall
Recall Action Instructions	ConMed is advising customers who have an affected Hyfrecator 2000 still in its original sealed carton (unopened) to return the product to ConMed for replacement. Customers who have an out-of-carton (opened) Hyfrecator 2000 are to check if they have any remaining sheaths (Ref. 70796-19) of the affected lots and to return unused affected sheaths for replacement. This action has been closed-out on 22/03/2018.
Contact Information	1800 238 238 - ConMed Australia Customer Service