Dilator, Vascular
- Recalling firm
- Getinge Australia Pty Ltd (NZ)
- Product
- Dilator, vascular. [Device]. Model: PIK dilator set L#; PIK 100#Insertion Kit, Guidewire 100 cm and PIK 150#Insertion Kit, Guidewire 150 cm. Affected: Part number: 701054427. All serial numbers; Part number:701047384 and 701047385. All serial numbers. Also covers: Catheterization kit, intravenous
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-08-06
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/5ca398b7-8628-45d6-87fd-bd958901744f