Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cranial Access (CRAK) Kits Recalled by Integra LifeSciences Corp. d.b.a. Integra Pain Management Due to Integra is recalling certain lots of Cranial Access...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. d.b.a. Integra Pain Management directly.
Affected Products
Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP.
Quantity: 8,648
Why Was This Recalled?
Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Integra LifeSciences Corp. d.b.a. Integra Pain Management
Integra LifeSciences Corp. d.b.a. Integra Pain Management has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report