Integra Cranial Access Kit Packaging Defect Compromises Sterility
Integra LifeSciences is recalling 180 Cranial Access Kits due to a packaging defect that can cause splits, compromising the sterility of the surgical device.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall where a packaging defect compromises the sterility of devices used in neurosurgery, creating a risk of infection. The defect presents potential for serious harm, meeting the rubric criterion for risk-of-harm products (Score 3).
Plain-English summary
Integra LifeSciences Corp. is recalling 180 units of the Integra® Cranial Access Kit (Catalog Number INS7280) used for access to the subarachnoid space or lateral ventricles of the brain during neurosurgery.
A defect in the outer packaging can cause the packaging to split without additional external force, compromising the sterility of the device. Non-sterile instruments in neurosurgical procedures create a risk of infection and contamination.
The affected units were distributed worldwide, including throughout the United States and to Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, and the United Kingdom. The affected lot numbers are 6788735 (expiration 1-Mar-25) and 7078240 (expiration 1-May-25).
Healthcare facilities and users who have these kits should immediately discontinue use, quarantine the affected units, and contact Integra LifeSciences Corp. for return and replacement instructions.
The recalled product
- Product
- Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7280
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- packaging-defect
- sterility-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI:10381780431947 Lot Number/Exp. Date: 6788735 1-Mar-25 7078240 1-May-25
Distribution
Distributed nationwide across the United States.
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