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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00854-1
Product Name/Description E-Z Clean, L-Wire Laparoscopic Electrode Split Stem, 45cm (Single use electrosurgical electrode)

Catalogue: MG0100LS

Lot Numbers: 131509, 131946

ARTG Number: 192262
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 12/08/2013
Responsible Entity Big Green Surgical Company Pty Ltd
Reason/Issue The distal portion of the electrode insulation of a small number of units may have been damaged during manufacture. In the event that a unit with damaged insulation is used on a patient contrary to recommended instructions for use supplied with the product, thermal damage could occur to the patient’s peripheral tissue. Such damage would be outside the surgeon’s primary field of view during a laparoscopic procedure and therefore not easily identified at the time of occurrence. .
Recall Action Recall
Recall Action Instructions Big Green Surgical is requesting users to quarantine all affected units. Affected stock will be replaced by Big Green Surgical or a credit note issued.
Contact Information 1300 244 473 - Big Green Surgical Customer Service