Integra LifeSciences recalls cranial access kits for brain surgery due to packaging defect that may split without compromising sterility. Affected kits have specific catalog numbers and expiration dates. Consumers should contact Integra for details.
Defect 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
Integra LifeSciences is recalling cranial access kits used in brain surgery because the outer packaging might split without losing sterility. This defect could lead to contamination if the kit is used improperly after splitting.
The packaging defect can split without external forces, potentially compromising the sterility of the surgical kit. This could lead to contamination if the kit is used after splitting, but the risk is low under normal use conditions.
Healthcare professionals who use these kits for brain surgery procedures are most at risk. The recall affects kits with specific catalog numbers and expiration dates listed in the product description.
Check for catalog numbers INS7250, 6500469, 6844175, or 7078238 with expiration dates of 1-Mar-25 or 1-May-25. The kits are for accessing the brain's subarachnoid space or lateral ventricles.
Reach out to Integra LifeSciences for specific details about your kit and instructions on next steps.
The outer packaging may split without external forces, potentially compromising sterility if used after splitting.
Contact Integra LifeSciences for details about your specific kit and instructions.
The risk is low under normal use conditions, but the packaging defect could lead to contamination if the kit splits.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0496-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-0496-2024 from Integra. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
