Integra Cranial Access Kit Recalled Due to Sterile Packaging Defect
Integra LifeSciences is recalling the Cranial Access Kit due to a defect in sterile packaging that could compromise product sterility. The device is used for neurosurgical access to the brain.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a risk-of-harm product (sterile surgical equipment for invasive neurosurgery) where sterility may be compromised due to packaging defect. No illnesses or injuries have been reported. The FDA Class II classification without reported harm indicates a score of 3 per the rubric.
Plain-English summary
Integra LifeSciences Corp. is recalling the Cranial Access Kit (Ref No: INSHITHRZN) due to a defect in the sterile packaging. This device is used to provide access to the subarachnoid space or lateral ventricles of the brain during neurosurgery.
The recall was initiated because the sterile packaging (header bag) has failed packaging integrity testing. When packaging integrity is compromised, the sterility of the device and its components may be compromised, potentially introducing contamination.
Approximately 6,093 units have been distributed worldwide, including throughout the United States and 19 other countries: Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, and the United Kingdom. Specific lot numbers and expiration dates are available through the FDA and the manufacturer.
Healthcare facilities and practitioners who have received affected units should contact Integra LifeSciences Corp. to confirm whether their inventory is affected and follow the manufacturer's guidance regarding device use or replacement.
The recalled product
- Product
- Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 6,093
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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