Integra LifeSciences recalls cranial access kits (model 10-110/INS-4500/INS-7040) due to packaging defect that could compromise sterility. Affected units have catalog number 31004 and lot 6926457. No remedy specified in recall notice.
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 that could have packaging defects leading to loss of sterility. This means the kits might not be sterile when used, which is dangerous for medical procedures.
The packaging defect could cause the outer packaging to split without external forces, potentially compromising the sterility of the medical devices. This means the kits might not be sterile when used in surgery, increasing infection risk.
Medical professionals who use these kits for brain surgery are most at risk. The recall affects specific kits sold with catalog number 31004 and lot number 6926457.
Check for catalog number 31004 and lot number 6926457 on the packaging. These kits are for accessing the brain's subarachnoid space or lateral ventricles during surgery.
Look for catalog number 31004 and lot number 6926457 on the packaging to identify affected units.
The outer packaging may split without external forces, potentially compromising sterility of the medical devices.
Check for catalog number 31004 and lot number 6926457 on the packaging.
The recall notice does not specify a remedy, so contact Integra LifeSciences for guidance.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0499-2024 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0499-2024 from Integra LifeSciences. 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.
