Integra LifeSciences recalls cranial access kits for brain surgery due to packaging defect that may split without external force, risking sterility. Affected units have specific catalog numbers and expiration dates.
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 external force, which could compromise the sterility of the surgical device. This defect affects kits with specific catalog numbers and expiration dates.
The outer packaging of the Cranial Access Kits may split without any external force, potentially compromising the sterility of the surgical device. This defect could lead to contamination during brain surgery if the packaging fails.
Healthcare professionals using the Integra Cranial Access Kits for brain surgery procedures are most at risk. The recall applies to specific catalog numbers and expiration dates listed in the notice.
Check for catalog numbers INS7280 and expiration dates 1-Mar-25 or 1-May-25 on the packaging. The recall applies to specific lots with these numbers.
Look for catalog numbers INS7280 and expiration dates 1-Mar-25 or 1-May-25 on the packaging.
The outer packaging may split without external force, potentially compromising the sterility of the surgical device.
Check for catalog numbers INS7280 and expiration dates 1-Mar-25 or 1-May-25 on the packaging. If you have these, contact Integra LifeSciences for further instructions.
The recall is for potential sterility compromise during surgery, not direct injury risk to users.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0494-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-0494-2024 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.
