Integra LifeSciences recalls INS7280 Cranial Access Kit due to potential sterility compromise from defective packaging. Affected units have specific lot numbers and expiration dates. Consumers should check their product details.
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 its INS7280 Cranial Access Kit because the sterile packaging might not be intact, risking contamination. This could lead to infections if the kit is used in medical procedures.
The sterile packaging for the Cranial Access Kit may have failed integrity tests, potentially allowing contamination. If the packaging is compromised, the kit could become unsterile, increasing infection risk during medical procedures.
Medical professionals who use this kit for brain surgery or procedures involving the subarachnoid space or lateral ventricles. Patients undergoing such procedures are at risk if the kit is used without proper sterility.
Check for the lot number 7127160 and expiration date 1-Sep-24 on the header bag. The product is labeled as INS7280 Cranial Access Kit for accessing the subarachnoid space or lateral ventricles of the brain.
Look for the lot number 7127160 and expiration date 1-Sep-24 on the header bag of the Cranial Access Kit.
The recall indicates potential sterility issues, so it is not recommended for use until the remedy is applied. The manufacturer has not provided a remedy, so affected units should be checked and handled carefully.
The recall record does not specify a remedy, so you should check the product details and contact Integra LifeSciences for further instructions.
Check for the lot number 7127160 and expiration date 1-Sep-24 on the header bag of the Cranial Access Kit.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1200-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-1200-2024 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.
