Cranial Access Kit recalled due to sterile packaging integrity defect
Integra LifeSciences is recalling a Cranial Access Kit due to packaging defects that may compromise sterility. The product was distributed worldwide.
What this means for you
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 potential sterility compromise of a neurosurgical device used in brain surgery. Although no illnesses or injuries have been reported and the sterility compromise is theoretical, the risk-of-harm to patients is significant given the critical nature of the affected device.
Plain-English summary
Integra LifeSciences Corp. has issued a nationwide and international recall of Cranial Access Kit, Ref No: 31156 (containing components INS-8301, INS-4500, and INS-HITH), used for accessing the subarachnoid space or lateral ventricles of the brain. The recall affects 4 units distributed worldwide, including the United States and multiple international locations.
The defect involves the sterile packaging (header bag) used for this neurosurgical device. Testing revealed that the packaging fails to meet required integrity criteria, which means the product sterility may be compromised. Integra LifeSciences identified this defect and initiated the recall.
Patients who have received this device or facilities that have this product in stock should contact Integra LifeSciences Corp. to determine if they have affected units. The recalled lot number is 7281021, with an expiration date of April 1, 2024.
The recalled product
- Product
- Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- sterility-compromise
- packaging-defect
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: 10381780178255 Lot Number: 7281021 Exp. Date: 1-Apr-24
Distribution
Distributed nationwide across the United States.
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