Integra Cranial Access Kit: Sterile Packaging Integrity Failure
Integra LifeSciences is recalling 23 units of the Cranial Access Kit due to defects in sterile packaging that may compromise product sterility. Units were 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 medical device used in neurosurgery where sterile packaging integrity testing has failed, potentially compromising sterility. The hazard is significant but theoretical—no illnesses or injuries have been reported—placing this in the High severity category.
Plain-English summary
Integra LifeSciences Corp. is recalling 23 units of the Integra Cranial Access Kit (Ref No: HITHSP06), a medical device designed for access to the subarachnoid space or lateral ventricles of the brain. The affected units are lot 7257029 with an expiration date of June 1, 2024.
The recall was initiated due to a defect in the sterile packaging (header bag) that failed required packaging integrity testing criteria. This defect may compromise the product's sterility.
The affected products were distributed worldwide, including the United States and Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, and the United Arab Emirates.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device — Neurosurgical
- Hazard
- packaging-defect
- sterility-compromise
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: 10381780263876 Lot Number: 7257029 Exp. Date: 1-Jun-24
Distribution
Distributed nationwide across the United States.
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