Integra Cranial Access Kit recalled due to packaging defect
Integra LifeSciences Corp. is recalling 173 units of its Cranial Access Kit due to a packaging defect that can split and compromise device sterility. No illnesses have been reported.
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 a Class II medical device recall with a packaging defect that can compromise sterility without external force. Although no illnesses or injuries have been reported, sterility compromise in a neurosurgical access device presents a risk of serious harm.
Plain-English summary
Integra LifeSciences Corp. is recalling the Integra Cranial Access Kit (Catalog Number HITHSP04), a medical device used for accessing the subarachnoid space or lateral ventricles of the brain. The recall affects 173 units.
The recall was initiated due to a defect in the outer packaging of the kits. The packaging can split without any external forces, which could compromise the sterility of the device.
The affected devices were distributed worldwide, including throughout the United States and to Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, and the United Kingdom. The recalled lot numbers are 6788615 (expiration 1-Dec-23) and 7002983 (expiration 1-Jan-24).
No illnesses or injuries have been reported in connection with this defect. Healthcare providers and facilities with affected units should contact Integra LifeSciences Corp. for further guidance.
The recalled product
- Product
- Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
- Manufacturer
- Integra LifeSciences Corp.
- 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 (2)
- UDI-DI: 10381780263869 Lot Number/Exp. Date: 6788615 1-Dec-23
- 7002983 1-Jan-24
Distribution
Distributed nationwide across the United States.
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