Integra LifeSciences recalls cranial access kits (without prep solutions) due to potential sterility compromise from defective packaging. Affected units include specific lot numbers and expiration dates. Consumers should contact Integra for 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 cranial access kits without prep solutions because their sterile packaging may have been compromised. This could lead to infections if the kit is used improperly. The recall affects specific lot numbers and expiration dates.
The sterile packaging for the cranial access kit failed integrity testing, which means the kit might not be sterile. If the kit is used without proper sterility, it could cause infections during surgery.
Medical professionals using the cranial access kits for brain surgery are most at risk. The recall applies to specific lot numbers and expiration dates listed in the product description.
Check the product label for lot numbers: 7249001, 7253133, 7253134, 7253135, 7253136, 7275711, or 7300837. The expiration date is listed as 29-Jun-25 through 16-Jul-25.
Look for lot numbers 7249001, 7253133, 7253134, 7253135, 7253136, 7275711, or 7300837 on the packaging.
The sterile packaging for the cranial access kit failed integrity testing, which could compromise sterility.
Check the product label for lot numbers listed in the recall. Contact Integra LifeSciences for further instructions.
The recall is due to potential sterility issues, not immediate injury risks. The danger level is low risk.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1196-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-1196-2024 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.
