Integra Cranial Access Kit recalled over outer packaging defect
Integra LifeSciences recalled the Integra Cranial Access Kit (160 units) due to a defect in the outer packaging that can split and compromise device sterility, creating an infection risk for neurosurgical procedures.
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 involving a packaging defect that compromises device sterility in a neurosurgical application. The source reports no illnesses or injuries, making this a risk-of-harm product where injury has not yet been reported, warranting a High severity rating per rubric criteria.
Plain-English summary
Integra LifeSciences Corp. has recalled the Integra Cranial Access Kit (Catalog Number HITHSP06), a medical device used for surgical access to the subarachnoid space or lateral ventricles of the brain. The recall affects 160 units distributed worldwide, including the United States, Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, and the United Kingdom.
The recall is prompted by a defect in the outer packaging of the kits. The defect allows the packaging to split without any additional external forces, which compromises the sterility of the device. A non-sterile surgical device used in neurosurgical procedures could pose a significant risk of infection.
The affected lot numbers are: 6844180 (expiration 1-Dec-23), 7028238 (expiration 1-Jan-24), 7078247 (expiration 17-Mar-24), and 7248995 (expiration 1-Jun-24). Healthcare facilities should verify their inventory against these lot numbers and the UDI-DI (10381780263876).
Healthcare providers and facilities with affected units should immediately stop using them and contact Integra LifeSciences Corp. This is a Class II FDA recall.
The recalled product
- Product
- Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- packaging-defect
- sterility-compromise
- infection-risk
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 (3)
- UDI-DI: 10381780263876 Lot Number/Exp. Date: 6844180 1-Dec-23
- 7028238 1-Jan-24
- 7078247 17-Mar-24 7248995 1-Jun-24
Distribution
Distributed nationwide across the United States.
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