Integra LifeSciences recalls cranial access kits for brain surgery due to packaging defect that may split without external force, risking 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 LifeSciences is recalling cranial access kits used in brain surgery because the outer packaging can split without external force, potentially compromising sterility. This defect could lead to infections or other complications during medical procedures.
The outer packaging of the cranial access kits can split without any external force, which may compromise the sterility of the surgical device. This could lead to infections or other complications during brain surgery procedures.
Healthcare professionals using the Integra Cranial Access Kit for brain surgery procedures are most at risk. Patients receiving these kits during surgery may be affected if the packaging splits.
Check for catalog numbers HITHSP04 and expiration dates 1-Dec-23 or 1-Jan-24 on the packaging. The kits are sold by Integra LifeSciences for brain surgery procedures.
Inspect the outer packaging for any signs of splitting or damage.
The outer packaging of the cranial access kits can split without external force, potentially compromising sterility during surgery.
The affected kits have catalog number HITHSP04.
The kits have expiration dates of 1-Dec-23 or 1-Jan-24.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0498-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-0498-2024 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.
