Cranial Access Kit Recall Due to Packaging Defect Compromising Sterility
Integra LifeSciences is recalling 485 Cranial Access Kits (Catalog INS7250) due to a packaging defect that can cause spontaneous splitting, compromising device sterility. The kits are used for surgical access to the brain.
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 recall involving a sterility-compromising packaging defect without reported hospitalizations or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
Integra LifeSciences Corp. is recalling the Integra Cranial Access Kit (Catalog Number INS7250), a medical device intended for access to the brain's subarachnoid space or lateral ventricles. The recall affects 485 units due to a defect in the outer packaging that can cause the packaging to split without external force, compromising device sterility.
The affected kits were distributed worldwide, including the United States and Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, and the United Kingdom. Affected lot numbers are 6500469 (expiring 1-Mar-25), 6844175 (expiring 1-Mar-25), and 7078238 (expiring 1-May-25).
Healthcare providers who have received affected kits should verify their inventory against the lot numbers and take appropriate action to prevent use of potentially compromised units.
The recalled product
- Product
- Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7250
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- sterility-compromise
- packaging-defect
Distribution
Distributed nationwide across the United States.
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