Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01154-1
Product Name/Description	Epidural Minipack Systems (Epidural anaesthesia kit) Product Number: 100/391/116 ARTG Number: 167342
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	8/11/2013
Responsible Entity	Smiths Medical Australasia Pty Ltd
Reason/Issue	The manufacturer is updating the Instructions for Use (IFU) for users should they experience difficulties removing the catheter during procedure. The wording in the current IFU states: "If resistance is felt upon withdrawal, consult current medical literature for specific techniques". This is to be replaced by: "If resistance is felt or if the catheter stretches excessively on withdrawal, cease removal. Never exert excessive force as this may compromise the integrity of the catheter. If clinically appropriate, reposition the patient (flex or extend, sit up or lay down) and slowly withdraw the catheter. If further resistance, repeat step and/or allow the patient to relax for several minutes/hours and attempt to remove later. if unable to remove, consult the anaesthetist. After removal, examine the catheter to ensure that the entire catheter with tip is intact. Should the top not be intact, consult the anaesthetist".
Recall Action	Recall for Product Correction
Recall Action Instructions	Smiths Medical is providing users with updated Instructions for Use (IFU) which includes the updated instructions.
Contact Information	1800 654 949 - Smith Medical Customer Service Department