Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27495 |
| Brand Name: | EPIDURAL SYSTEM |
| Model: | |
| Affected: | Part number 100/390/116; lot number 3940429 |
| 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 ASD Inc |
| Issue: | The manfacturer became aware that a Portex Epidural Maxipack 16G (Part number 100/390/116; lot number 3940429) contained an 18G epidural catheter. The clinician reported difficulty threading the 18g catheter through the 16g needle (the thinner 18g catheter was not well supported by the larger diameter 16g needle) and injecting epidural medication resulting in a delay in initiation of therapy. |
| Recall action type: | Recall |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 24/3/2021 |
