| TGA Action ID |
RC-2026-RN-00580-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Percutaneous Insertion Kits (PIK)
PIK 100#Insertion Kit, Guidewire 100 cm
Part Number: 701047384
PIK 150#Insertion Kit, Guidewire 150 cm
Part Number: 701047385
PIK dilator set L
#Part Number: 701054427
All Serial Numbers |
| ARTG Number |
266173, 360110 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
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. The manufacturer became aware of this problem during retrospective review of historical packaging verification documentation.
Patients may be exposed to pathogens in/on the medical device in direct (or indirect) contact to the vascular system which could lead to infection.
There have been two associated customer complaint reports detected during unpacking of the product before clinical use, none report patient harm, serious injuries, or deaths. |
| Instructions for Customers/Users |
Customers are to:
- Check inventory immediately and quarantine any affected product on hand.
- Return all affected products to the local Getinge representative and contact them to arrange a credit.
- Continue use of products currently in use in accordance with the instructions for use.
- Monitor patients in accordance with the facility care standards.
- Always report any adverse events, e.g., infections, potentially related to the affected products, to Getinge. |
| Action Commencement Date |
4/08/2026 |
| Responsible Entity |
|
| Contact Information |
1800 438 464 - Getinge Customer Service |