Cranial Access Kit Packaging Defect May Compromise Sterility
Integra LifeSciences is recalling a cranial access kit due to a packaging defect that can cause the sterile outer packaging to split without additional force, potentially compromising device 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: FDA Class II recall affecting a sterility-critical surgical device. While no illnesses or injuries have been reported, this is a risk-of-harm product in a high-risk neurosurgical application where a packaging defect compromises sterility, creating potential for serious infection.
Plain-English summary
Integra LifeSciences Corp. is recalling the Combo Kit (Catalog Number 31004), a surgical device used for accessing the subarachnoid space or lateral ventricles during brain procedures.
The kit's outer packaging has a defect that can split without additional external force, compromising the sterility of the device. Maintaining sterility is critical for surgical instruments used in neurosurgical procedures.
The affected lot (6926457, expiration date 31-May-24) was distributed worldwide to the United States and to Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, and the United Kingdom.
Healthcare providers should discontinue use of affected units and contact Integra LifeSciences for return or replacement instructions. No illnesses or injuries have been reported.
The recalled product
- Product
- Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: 31004
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 1
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: 10381780178095 Lot Number/Exp. Date: 6926457 31-May-24
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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