Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15637 |
| Brand Name: | Smiths Medical Epidural Minipack Systems |
| Model: | 100/391/116 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Smiths Medical Australasia Pty Ltd c/o KPMG, KPMG Centre 18 Viaduct Harbour Avenue Auckland |
| Contact Information: | 0800 444 200 |
| Manufacturer: | Smiths Medical International Ltd (UK) |
| Issue: | 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 anesthetist. After removal, examine the catheter to ensure that the entire catheter with tip is intact. Should the tip not be intact, consult the anesthetist" |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/11/2013 |
