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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