Integra recalls cranial access kits (without prep solutions) due to packaging defect that may split without compromising sterility. Affected kits have specific catalog numbers and expiration dates. Consumers should contact Integra for details.
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 is recalling cranial access kits (without prep solutions) because the outer packaging can split without affecting the sterility of the device. This defect could lead to contamination if the packaging splits during use.
The outer packaging of the cranial access kits can split without any external force compromising the sterility of the device. This means the kits could become contaminated if the packaging splits during use, potentially leading to infection.
Medical professionals who use these kits for brain surgery are most at risk. The recall affects specific catalog numbers and expiration dates listed in the product description.
Check for catalog numbers: INS5HND. Expiration dates include May 30, 2025 through October 30, 2025. The kits are sold with specific lot numbers listed in the product description.
Reach out to Integra LifeSciences Corp. for specific instructions on how to handle the recalled kits.
The recall does not require immediate discontinuation; contact Integra for specific instructions.
The catalog number for the recalled kits is INS5HND.
The kits have expiration dates ranging from May 30, 2025 to October 30, 2025.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0491-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-0491-2024 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.
