OFFICIAL-SOURCE RECALL · AUSTRALIA
Percutaneous Insertion Kits (PIK) Recall: Classification Class II Reason for the Action It was
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
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Is your product affected?
- Brand
- See official notice
- Product
- Percutaneous Insertion Kits (PIK)
- Manufacturer
- See official notice
- Lot number
- numbers
- Batch number
- numbers
- Serial number / range
- Numbers
- Date code
- dates
- Expiration date
- dates
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
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)
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)
Official recall notice
Percutaneous Insertion Kits (PIK)
Agency: Therapeutic Goods Administration
Official publication date: August 4, 2026
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