Integra recalls cranial access kits for brain surgery due to packaging defect that may split without compromising sterility. Affected kits have specific catalog numbers and expiration dates.
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 used for brain surgery because the outer packaging might split without losing sterility. This could lead to infection risks if the kit is used after the packaging splits.
The outer packaging of the cranial access kits can split without external forces compromising the sterility of the device. This defect may allow bacteria to enter the surgical site, increasing infection risk during procedures.
Healthcare professionals who use Integra's cranial access kits for brain surgery are most at risk. Patients receiving these kits during procedures may be affected if the packaging splits.
Check for catalog numbers HITHSP06 with specific lot numbers: 6844180 (exp. 1-Dec-23), 7028238 (exp. 1-Jan-24), 7078247 (exp. 17-Mar-24), and 7248995 (exp. 1-Jun-24).
Inspect the outer packaging for signs of splitting before use. If split, do not use the kit.
The outer packaging of the cranial access kits may split without compromising sterility, potentially increasing infection risk during surgery.
Catalog number HITHSP06 with lot numbers 6844180 (exp. 1-Dec-23), 7028238 (exp. 1-Jan-24), 7078247 (exp. 17-Mar-24), and 7248995 (exp. 1-Jun-24).
Look for the catalog number HITHSP06 on the packaging with the specific lot numbers listed above.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0497-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-0497-2024 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.
