Integra Cranial Access Kit recall over sterile packaging defect
Integra LifeSciences is recalling the Cranial Access Kit due to a defect in the sterile packaging that may compromise product sterility. Affects 30 units distributed worldwide.
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 an FDA Class II recall for a sterile surgical device used in neurosurgery. Although no illnesses or injuries have been reported, the packaging defect creates a potential risk of harm by compromising sterility in a device used near the brain.
Plain-English summary
Integra LifeSciences Corp. is recalling the Cranial Access Kit (Ref No: INS7270), a surgical device used for access to the subarachnoid space or lateral ventricles of the brain. The recall affects 30 units with Lot Number 7257036 (expiration date 1-Sep-24).
The recall was issued because the sterile packaging (header bag) of the kit failed required packaging integrity testing criteria. This defect may compromise the product's sterility. No illnesses or injuries have been reported to date.
The recalled kits were distributed worldwide, including to the United States and to Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, and the United Arab Emirates.
Customers who have received this product should contact Integra LifeSciences Corp. for instructions on return or replacement. Healthcare providers and patients should not use the recalled kits.
The recalled product
- Product
- Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device
- Affected units
- 30
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: 10381780431930 Lot Number: 7257036 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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