Integra LifeSciences recalls Cranial Access Kit (Ref No: INS7270) due to potential sterility compromise from defective packaging. Affected units sold with lot number 7257036 expiring 1-Sep-24.
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 their Cranial Access Kit (Ref No: INS7270) because the sterile packaging might not be intact, risking contamination during medical procedures. This could lead to infections or other complications if the kit is used improperly.
The sterile packaging (header bag) of the Cranial Access Kit failed integrity testing, which could mean the kit is not sterile when opened. This might lead to contamination during medical procedures, potentially causing infections or other complications.
Medical professionals using the kit for brain surgery or procedures involving the subarachnoid space or lateral ventricles. Patients undergoing these procedures are at risk if the kit is used without proper sterility.
Check for the product name 'Integra Cranial Access Kit' with reference number INS7270. Affected units have lot number 7257036 and expire on September 1, 2024.
Inspect the header bag for signs of damage or improper sealing. If the bag appears compromised, do not use the kit.
The recall is for medical professionals using the kit during procedures. Patients are not directly affected unless the kit is used without proper sterility.
Look for the product name 'Integra Cranial Access Kit' with reference number INS7270. Affected units have lot number 7257036 and expire on September 1, 2024.
Check the packaging for damage or improper sealing. If the header bag appears compromised, do not use the kit. Contact Integra LifeSciences for further guidance.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1199-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-1199-2024 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.
