Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28290 |
| Brand Name: | Park Blade Septostomy Catheter |
| Model: | |
| Affected: | IFU update for the Park Blade Septostomy Catheter |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | Cook Group Inc |
| Issue: | The manufacturer has implemented an IFU update for the Park Blade Septostomy Catheter. Product label and IFU have been updated per Change Order C00062783. All Park Blade Septostomy Catheters have been removed from the EU. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/9/2021 |
