Integra Cranial Access Kit Recall Due to Sterile Packaging Defect
Integra LifeSciences is recalling the INS7280 Cranial Access Kit due to a packaging defect that may compromise product sterility. The recall affects 82 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 involving a sterile packaging defect on a medical device used in neurosurgery. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported merit a High (3) severity score.
Plain-English summary
Integra LifeSciences Corp. is recalling the INS7280 / Integra Cranial Access Kit, a medical device for access to the subarachnoid space or lateral ventricles of the brain.
The recall is due to a defect in the sterile packaging (header bag) that fails required packaging integrity testing criteria, which may compromise the product's sterility. The recall affects 82 units with Lot Number 7127160, which expire on September 1, 2024.
The affected devices 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, and the United Arab Emirates.
Recipients of affected devices should not use them and should contact Integra LifeSciences Corp. immediately for information about returns and proper disposal.
The recalled product
- Product
- INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 82
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: 10381780431947 Lot Number: 7127160 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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