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Integra LifeSciences Corp. Recall: Integra Cranial Access Kit - For access to the subarach

Integra LifeSciences Corp. Recall: Integra Cranial Access Kit - For access to the subarach is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Integra LifeSciences Corp.; Product: Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Cata

Recalling firmIntegra LifeSciences Corp.
ProductIntegra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Reason for recallDefect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionWorldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.
Recall initiated20231019
Recall numberZ-0493-2024
Categorydevice
StateNJ
CountryUnited States

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