Integra LifeSciences recalls Cranial Access Kit (Ref No: INS7260) due to potential sterility compromise from defective packaging. Affected units include specific lot numbers sold through medical channels.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Integra LifeSciences is recalling a Cranial Access Kit used in brain surgery procedures because its sterile packaging might be compromised. This could lead to infections if the kit is used without proper sterility.
The sterile packaging for the Cranial Access Kit failed integrity testing, meaning the kit might not be sterile when opened. If used without proper sterility, this could cause infections during surgery.
Medical professionals using the Cranial Access Kit for brain surgery procedures are most at risk. The recall affects specific lot numbers sold to hospitals and surgical centers.
Check for the lot number 7124720 on the packaging. The kit was sold with expiration date 1-Sep-24. This product is used in medical settings for brain surgery procedures.
Look for lot number 7124720 and expiration date 1-Sep-24 on the packaging.
The recall indicates potential sterility issues, so it is not recommended for use until the recall is addressed.
The recall does not specify a remedy, so contact Integra LifeSciences for guidance on next steps.
Check for lot number 7124720 and expiration date 1-Sep-24 on the packaging.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1198-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-1198-2024 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.
