Integra LifeSciences recalls Cranial Access Kit (Ref No: INS7250) due to potential sterility compromise from defective packaging. Affected units sold with specific lot numbers and expiration dates.
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 Cranial Access Kit (Ref No: INS7250) because the sterile packaging may 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 of the Cranial Access Kit may have failed integrity testing, meaning the kit could become contaminated. This contamination could lead to infections or other complications during medical procedures if the kit is used without proper sterility.
Healthcare professionals using the Cranial Access Kit for brain surgery procedures are most at risk. Patients receiving this kit during surgery could be affected if the packaging fails.
Check for the product name 'Integra Cranial Access Kit' with Ref No: INS7250. Affected units have Lot Number 7124718 and expire September 1, 2024.
Inspect the header bag for signs of damage or improper sealing.
The recall indicates potential sterility issues, so it is not recommended for use until the packaging is verified as intact.
The recall does not specify a remedy, so contact Integra LifeSciences for guidance on safe handling.
Look for the product name 'Integra Cranial Access Kit' with Ref No: INS7250, Lot Number 7124718, and expiration date September 1, 2024.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1197-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-1197-2024 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.
