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 in brain surgery because the outer packaging can split without losing sterility. This defect could lead to contamination during procedures if the packaging fails.
The packaging defect can split without external forces affecting the sterility of the surgical kit. This means the kit might become contaminated during use if the packaging fails, though the defect doesn't cause immediate harm.
Surgical teams using Integra Cranial Access Kits for brain procedures are affected. The risk is low as the defect doesn't compromise sterility under normal use conditions.
Check for catalog numbers INS7270 (expiring 1-Aug-24) or INS7270 (expiring 1-Sep-24) on the packaging. The kits are sold for brain surgery access procedures.
Inspect the outer packaging for signs of splitting or damage.
The recall is for a packaging defect that may split without compromising sterility. It does not pose an immediate risk of injury or contamination under normal use conditions.
Look for catalog numbers INS7270 (expiring 1-Aug-24) or INS7270 (expiring 1-Sep-24) on the packaging.
Inspect the packaging for signs of splitting. If you find damage, contact Integra LifeSciences for guidance.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0492-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-0492-2024 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.
