Integra Cranial Access Kit Recalled Due to Packaging Integrity Defect
Integra LifeSciences is recalling 188 units of the Integra Cranial Access Kit because defective sterile packaging may have compromised product sterility.
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 medical device used in neurosurgery with potential risk of serious harm if sterility is compromised. No illnesses or injuries have been reported and the hazard is theoretical, making this a risk-of-harm product where injury has not yet been reported, which meets the High (3) severity criteria.
Plain-English summary
Integra LifeSciences Corp. is recalling the Integra Cranial Access Kit (Ref No: INS7250) used for access to the subarachnoid space or lateral ventricles of the brain. The recall affects 188 units with lot number 7124718 and expiration date of September 1, 2024.
The product is being recalled due to a defect in the sterile packaging (header bag) that failed required packaging integrity testing criteria. This defect may compromise the sterility of the product.
The affected units have been distributed worldwide, including throughout the United States and in Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, the United Arab Emirates, and the United Kingdom.
This is a Class II recall. No illnesses or injuries have been reported.
The recalled product
- Product
- Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 188
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:10381780431916 Lot Number: 7124718 Exp Date: 1-Sep-24
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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