Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37212 |
| Brand Name: | Dilator, vascular |
| Model: | PIK dilator set L# |
| Affected: | Part number: 701054427. All serial numbers |
| Software version: | |
| Recalling Organisation: | Getinge Australia Pty Ltd (NZ) Unit D, Ground Floor, Building A, Millenium Centre 600 Great South Rd Ellerslie Auckland 1051 |
| Contact Information: | 09 272 9039 |
| Manufacturer: | Maquet Cardio Pulmonary GmbH |
| Brand Name: | Catheterization kit, intravenous |
| Model: | PIK 100#Insertion Kit, Guidewire 100 cm and PIK 150#Insertion Kit, Guidewire 150 cm |
| Affected: | Part number:701047384 and 701047385. All serial numbers |
| Software version: | |
| Recalling Organisation: | Getinge Australia Pty Ltd (NZ) Unit D, Ground Floor, Building A, Millenium Centre 600 Great South Rd Ellerslie Auckland 1051 |
| Contact Information: | 09 272 9039 |
| Manufacturer: | Maquet Cardio Pulmonary GmbH |
| Issue: | The manufacturer became aware of this problem during retrospective review of historical packaging verification documentation. It was identified that there have been failures in sterile barrier integrity verification testing. As these failures were not previously addressed in accordance with packaging verification requirements, the packaging may not consistently maintain sterile barrier integrity. Therefore, this Product Recall is limited to all products of the PIK line within shelf-life. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 6/8/2026 |
