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.
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 for brain surgery because the outer packaging might split without losing sterility. This could lead to infection or other complications if the kit is used improperly after splitting.
The packaging defect can cause the outer layer to split without any external force needed. This might compromise the sterility of the surgical kit, increasing the risk of infection or other complications during brain surgery.
Healthcare professionals who use these kits for brain surgery procedures are most at risk. Patients receiving these kits during surgery may be affected if the packaging splits during use.
Check for catalog numbers INS7260, 6561324 (exp. 1-Aug-24), 6844177 (exp. 1-Mar-25), or 7078242 (exp. 1-May-25) on the packaging. These kits were sold for brain surgery procedures.
Inspect the outer packaging for any signs of splitting or damage.
The outer packaging of the Cranial Access Kits may split without any external force, potentially compromising sterility.
Check the packaging for signs of splitting and contact Integra LifeSciences for further instructions.
Yes, the packaging defect could lead to infection or other complications if the kit is used after the packaging splits.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0495-2024 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0495-2024 from Integra LifeSciences. 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.
